[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Proposed Rules]
[Pages 95810-95846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30645]
[[Page 95809]]
Vol. 81
Wednesday,
No. 249
December 28, 2016
Part IV
Environmental Protection Agency
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40 CFR Part 63
National Emission Standards for Hazardous Air Pollutants: Nutritional
Yeast Manufacturing Risk and Technology Review; Proposed Rule
Federal Register / Vol. 81 , No. 249 / Wednesday, December 28, 2016 /
Proposed Rules
[[Page 95810]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2015-0730; FRL-9956-21-OAR]
RIN 2060-AS93
National Emission Standards for Hazardous Air Pollutants:
Nutritional Yeast Manufacturing Risk and Technology Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing
amendments to the National Emission Standards for Hazardous Air
Pollutants (NESHAP) for the Manufacturing of Nutritional Yeast source
category. The proposed amendments address the results of the residual
risk and technology reviews (RTRs) conducted as required under the
Clean Air Act (CAA) as well as other actions deemed appropriate during
the review of these standards. The proposed amendments include revising
the form of the fermenter volatile organic compounds (VOC) emission
limits, changing the testing and monitoring requirements, and updating
the reporting and recordkeeping requirements.
DATES: Comments. Comments must be received on or before February 13,
2017. Under the Paperwork Reduction Act (PRA), comments on the
information collection provisions are best assured of consideration if
the Office of Management and Budget (OMB) receives a copy of your
comments on or before January 27, 2017.
Public Hearing. A public hearing will be held, if requested by
January 3, 2017.
ADDRESSES: Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2015-0730, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Allison Costa, Sector Policies and Programs Division
(Mail Code E140), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number: (919) 541-1322; fax number: (919) 541-3470;
and email address: costa.allison@epa.gov. For specific information
regarding the risk modeling methodology, contact Chris Sarsony, Health
and Environmental Impacts Division (Mail Code C539-02), Office of Air
Quality Planning and Standards, U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina 27711; telephone number: (919)
541-4843; fax number: (919) 541-0840; and email address:
sarsony.chris@epa.gov. For information about the applicability of the
NESHAP to a particular entity, contact Scott Throwe, Office of
Enforcement and Compliance Assurance, U.S. Environmental Protection
Agency, EPA WJC South Building (Mail Code 2227A), 1200 Pennsylvania
Avenue NW., Washington, DC 20460; telephone number: (919) 564-7013; fax
number: (202) 564-0050; and email address: throwe.scott@epa.gov.
SUPPLEMENTARY INFORMATION:
Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2015-0730. All documents in the docket are
listed in the Regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in Regulations.gov or in
hard copy at the EPA Docket Center, Room 3334, EPA WJC West Building,
1301 Constitution Avenue NW., Washington, DC. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the EPA Docket Center is
(202) 566-1742.
Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2015-0730. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be CBI or other information whose disclosure is restricted by
statute. Do not submit information that you consider to be CBI or
otherwise protected through http://www.regulations.gov or email. The
http://www.regulations.gov Web site is an ``anonymous access'' system,
which means the EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to the EPA without going through http://www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should not include
special characters or any form of encryption and be free of any defects
or viruses. For additional information about the EPA's public docket,
visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
Public Hearing. A public hearing will be held, if requested by
January 3, 2017, to accept oral comments on this proposed action. If a
hearing is requested, it will be held at the EPA's North Carolina
campus located at 109 T.W. Alexander Drive, Research Triangle Park, NC
27711. The hearing, if requested, will begin at 9:00 a.m. (local time)
and will conclude at 8:00 p.m. (local time). To request a hearing, to
register to speak at a hearing, or to inquire if a hearing will be
held, please contact Aimee St. Clair at (919) 541-1063 or by email at
StClair.Aimee@epa.gov. The last day to pre-register to speak at a
hearing, if one is held, will be January 10, 2017. Additionally,
requests to speak will be taken the day of the hearing at the hearing
registration desk, although preferences on speaking times may not be
able to be fulfilled. Please note that registration requests
[[Page 95811]]
received before the hearing will be confirmed by the EPA via email. The
EPA will make every effort to accommodate all speakers who arrive and
register. Because the hearing will be held at a U.S. governmental
facility, individuals planning to attend the hearing should be prepared
to show valid picture identification to the security staff in order to
gain access to the meeting room. Please note that the REAL ID Act,
passed by Congress in 2005, established new requirements for entering
federal facilities. If your driver's license is issued by Alaska,
American Samoa, Arizona, Kentucky, Louisiana, Maine, Massachusetts,
Minnesota, Montana, New York, Oklahoma or the state of Washington, you
must present an additional form of identification to enter the federal
building. Acceptable alternative forms of identification include:
federal employee badges, passports, enhanced driver's licenses and
military identification cards. In addition, you will need to obtain a
property pass for any personal belongings you bring with you. Upon
leaving the building, you will be required to return this property pass
to the security desk. No large signs will be allowed in the building,
cameras may only be used outside of the building and demonstrations
will not be allowed on federal property for security reasons.
Please note that any updates made to any aspect of the hearing,
including whether or not a hearing will be held, will be posted online
at https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards. We ask that you contact
Aimee St. Clair at (919) 541-1063 or by email at StClair.Aimee@epa.gov
or monitor our Web site to determine if a hearing will be held. The EPA
does not intend to publish a notice in the Federal Register announcing
any such updates. Please go to https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards for more information on the public hearing.
Preamble Acronyms and Abbreviations. We use multiple acronyms and
terms in this preamble. While this list may not be exhaustive, to ease
the reading of this preamble and for reference purposes, the EPA
defines the following terms and acronyms here:
AEGL Acute exposure guideline levels
AERMOD Air dispersion model used by the HEM-3 model
ATSDR Agency for Toxic Substances and Disease Registry
CAA Clean Air Act
CalEPA California EPA
CBI Confidential Business Information
CDX Central Data Exchange
CEDRI Compliance and Emissions Data Reporting Interface
CEMS Continuous emission monitoring system
CFR Code of Federal Regulations
EGU Electric generation unit
EPA Environmental Protection Agency
ERPG Emergency Response Planning Guidelines
FR Federal Register
HAP Hazardous air pollutants
HCl Hydrochloric acid
HEM-3 Human Exposure Model, Version 1.1.0
HF Hydrogen fluoride
HI Hazard index
HQ Hazard quotient
ICR Information Collection Request
IRIS Integrated Risk Information System
km Kilometer
MACT Maximum achievable control technology
MATS Mercury Air Toxics Standard
mg/kg-day Milligrams per kilogram per day
mg/m\3\ Milligrams per cubic meter
MIR Maximum individual risk
MON Miscellaneous organic chemical manufacturing NESHAP
NAAQS National Ambient Air Quality Standards
NAICS North American Industry Classification System
NAS National Academy of Sciences
NATA National Air Toxics Assessment
NEI National Emissions Inventory
NESHAP National emissions standards for hazardous air pollutants
NOX Nitrogen oxides
NRC National Research Council
QA/QC Quality assurance/quality control
OAQPS Office of Air Quality Planning and Standards
OMB Office of Management and Budget
PB-HAP Hazardous air pollutants known to be persistent and bio-
accumulative in the environment
POM Polycyclic organic matter
ppmv Parts per million by volume
PRA Paperwork Reduction Act
PS Performance Specification
RBLC RACT/BACT/LAER Clearinghouse
REL Reference exposure level
RFA Regulatory Flexibility Act
RfC Reference concentration
RfD Reference dose
RTO Regenerative thermal oxidizer
RTR Residual risk and technology review
SAB Science Advisory Board
SBA Small Business Administration
SOP Standing Operating Procedures
SSM Startup, shutdown, and malfunction
TOSHI Target organ-specific hazard index
tpy Tons per year
TRIM.FaTE Total Risk Integrated Methodology. Fate, Transport, and
Ecological Exposure model
TTN Technology Transfer Network
UF Uncertainty factor
[micro]g/m\3\ Microgram per cubic meter
UMRA Unfunded Mandates Reform Act
URE Unit risk estimate
VOC Volatile organic compounds
Organization of this Document. The information in this preamble is
organized as follows:
I. General Information
A. Does this action apply to me?
B. Where can I get a copy of this document and other related
information?
C. What should I consider as I prepare my comments for the EPA?
II. Background
A. What is the statutory authority for this action?
B. What is this source category and how does the current NESHAP
regulate its HAP emissions?
C. What data collection activities were conducted to support
this action?
D. What other relevant background information and data are
available?
III. Analytical Procedures
A. How did we estimate post-MACT risks posed by the source
category?
B. How did we consider the risk results in making decisions for
this proposal?
C. How did we perform the technology review?
IV. Analytical Results and Proposed Decisions
A. What are the results of the risk assessment and analyses?
B. What are our proposed decisions regarding risk acceptability,
ample margin of safety, and adverse environmental effects?
C. What are the results and proposed decisions based on our
technology review?
D. What other actions are we proposing?
E. What compliance dates are we proposing?
V. Summary of Cost, Environmental, and Economic Impacts
A. What are the affected sources?
B. What are the air quality impacts?
C. What are the cost impacts?
D. What are the economic impacts?
E. What are the benefits?
VI. Request for Comments
VII. Submitting Data Corrections
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
B. Paperwork Reduction Act (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act (NTTAA) and
1 CFR part 51
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
[[Page 95812]]
I. General Information
A. Does this action apply to me?
Table 1 of this preamble lists the NESHAP and the associated
regulated industrial source category that is the subject of this
proposal. Table 1 is not intended to be exhaustive, but rather provides
a guide for readers regarding the entities that this proposed action is
likely to affect. The proposed standards, once promulgated, will be
directly applicable to the affected sources. Federal, state, local, and
tribal government entities would not be affected by this proposed
action. As defined in the Initial List of Categories of Sources Under
Section 112(c)(1) of the Clean Air Act Amendments of 1990 (see 57 FR
31576, July 16, 1992), the Manufacturing of Nutritional Yeast source
category includes any facility engaged in the manufacture of baker's
yeast by fermentation (both active dry yeast and compressed yeast). The
category includes, but is not limited to, the following manufacturing
process units: fermentation vessels and the drying and packaging
system. The original source category was named Baker's Yeast
Manufacturing, but it was revised to Manufacturing of Nutritional Yeast
to provide clarity on the scope (63 FR 55812, October 19, 1998).
Table 1--NESHAP and Industrial Source Categories Affected By This
Proposed Action
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NESHAP and source category NAICS code \1\
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Manufacturing of Nutritional Yeast...................... 311999
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\1\ North American Industry Classification System (NAICS).
B. Where can I get a copy of this document and other related
information?
In addition to being available in the docket, an electronic copy of
this action is available on the Internet. Following signature by the
EPA Administrator, the EPA will post a copy of this proposed action at
https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards. Following publication in
the Federal Register, the EPA will post the Federal Register version of
the proposal and key technical documents at this same Web site.
Information on the overall RTR program is available at https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.
C. What should I consider as I prepare my comments for the EPA?
Submitting CBI. Do not submit information containing CBI to the EPA
through http://www.regulations.gov or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
a disk or CD-ROM that you mail to the EPA, mark the outside of the disk
or CD-ROM as CBI and then identify electronically within the disk or
CD-ROM the specific information that is claimed as CBI. In addition to
one complete version of the comments that includes information claimed
as CBI, you must submit a copy of the comments that does not contain
the information claimed as CBI for inclusion in the public docket. If
you submit a CD-ROM or disk that does not contain CBI, mark the outside
of the disk or CD-ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and the EPA's
electronic public docket without prior notice. Information marked as
CBI will not be disclosed except in accordance with procedures set
forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver
information identified as CBI only to the following address: OAQPS
Document Control Officer (C404-02), OAQPS, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711,
Attention Docket ID No. EPA-HQ-OAR-2015-0730.
II. Background
A. What is the statutory authority for this action?
Section 112 of the CAA establishes a two-stage regulatory process
to address emissions of hazardous air pollutants (HAP) from stationary
sources. In the first stage, after the EPA has identified categories of
sources emitting one or more of the HAP listed in CAA section 112(b),
CAA section 112(d) requires us to promulgate technology-based NESHAP
for those sources. ``Major sources'' are those that emit or have the
potential to emit 10 tons per year (tpy) or more of a single HAP or 25
tpy or more of any combination of HAP. For major sources, the
technology-based NESHAP must reflect the maximum degree of emission
reductions of HAP achievable (after considering cost, energy
requirements and non-air quality health and environmental impacts) and
are commonly referred to as maximum achievable control technology
(MACT) standards.
MACT standards must reflect the maximum degree of emissions
reduction achievable through the application of measures, processes,
methods, systems or techniques, including, but not limited to, measures
that: (1) Reduce the volume of or eliminate pollutants through process
changes, substitution of materials, or other modifications; (2) enclose
systems or processes to eliminate emissions; (3) capture or treat
pollutants when released from a process, stack, storage, or fugitive
emissions point; (4) are design, equipment, work practice, or
operational standards (including requirements for operator training or
certification); or (5) are a combination of the above. CAA section
112(d)(2)(A)-(E). The MACT standards may take the form of design,
equipment, work practice, or operational standards where the EPA first
determines either that: (1) A pollutant cannot be emitted through a
conveyance designed and constructed to emit or capture the pollutant,
or that any requirement for, or use of, such a conveyance would be
inconsistent with law; or (2) the application of measurement
methodology to a particular class of sources is not practicable due to
technological and economic limitations. CAA section 112(h)(1)-(2).
The MACT ``floor'' is the minimum control level allowed for MACT
standards promulgated under CAA section 112(d)(3) and may not be based
on cost considerations. For new sources, the MACT floor cannot be less
stringent than the emissions control that is achieved in practice by
the best-controlled similar source. The MACT floor for existing sources
can be less stringent than floors for new sources, but not less
stringent than the average emissions limitation achieved by the best-
performing 12 percent of existing sources in the category or
subcategory (or the best-performing five sources for categories or
subcategories with fewer than 30 sources). In developing MACT
standards, the EPA must also consider control options that are more
stringent than the floor. We may establish standards more stringent
than the floor based on considerations of the cost of achieving the
emission reductions, any non-air quality health and environmental
impacts, and energy requirements.
The EPA is then required to review these technology-based standards
and revise them ``as necessary (taking into account developments in
practices, processes, and control technologies)'' no less frequently
than every 8 years. CAA section 112(d)(6). In conducting this review,
the EPA is not required to recalculate the MACT floor. Natural
Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077, 1084 (D.C. Cir.
2008). Association of Battery Recyclers,
[[Page 95813]]
Inc. v. EPA, 716 F.3d 667 (D.C. Cir. 2013).
The second stage in standard-setting focuses on reducing any
remaining (i.e., ``residual'') risk according to CAA section 112(f).
CAA section 112(f)(1) required that the EPA prepare a report to
Congress discussing (among other things) methods of calculating the
risks posed (or potentially posed) by sources after implementation of
the MACT standards, the public health significance of those risks, and
the EPA's recommendations as to legislation regarding such remaining
risk. The EPA prepared and submitted the ``Residual Risk Report to
Congress,'' EPA-453/R-99-001 (``Risk Report'') in March 1999. CAA
section 112(f)(2) then provides that if Congress does not act on any
recommendation in the Risk Report, the EPA must analyze and address
residual risk for each category or subcategory of sources 8 years after
promulgation of such standards pursuant to CAA section 112(d).
Section 112(f)(2) of the CAA requires the EPA to determine for
source categories subject to MACT standards whether the emission
standards provide an ample margin of safety to protect public health.
Section 112(f)(2)(B) of the CAA expressly preserves the EPA's use of
the two-step process for developing standards to address any residual
risk and the Agency's interpretation of ``ample margin of safety''
developed in the National Emissions Standards for Hazardous Air
Pollutants: Benzene Emissions from Maleic Anhydride Plants,
Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment
Leaks, and Coke By-Product Recovery Plants (Benzene NESHAP) (54 FR
38044, September 14, 1989). The EPA notified Congress in the Risk
Report that the Agency intended to use the Benzene NESHAP approach in
making CAA section 112(f) residual risk determinations (EPA-453/R-99-
001, p. ES-11). The EPA subsequently adopted this approach in its
residual risk determinations and in a challenge to the risk review for
the Synthetic Organic Chemical Manufacturing source category, the
United States Court of Appeals for the District of Columbia Circuit
upheld as reasonable the EPA's interpretation that CAA section
112(f)(2) incorporates the approach established in the Benzene NESHAP.
See NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008)(``[S]ubsection
112(f)(2)(B) expressly incorporates the EPA's interpretation of the
Clean Air Act from the Benzene standard, complete with a citation to
the Federal Register.''); see also, A Legislative History of the Clean
Air Act Amendments of 1990, vol. 1, p. 877 (Senate debate on Conference
Report).
The first step in the process of evaluating residual risk is the
determination of acceptable risk. If risks are unacceptable, the EPA
cannot consider cost in identifying the emissions standards necessary
to bring risks to an acceptable level. The second step is the
determination of whether standards must be further revised in order to
provide an ample margin of safety to protect public health. The ample
margin of safety is the level at which the standards must be set,
unless an even more stringent standard is necessary to prevent, taking
into consideration costs, energy, safety, and other relevant factors,
an adverse environmental effect.
1. Step 1--Determination of Acceptability
The Agency in the Benzene NESHAP concluded that ``the acceptability
of risk under section 112 is best judged on the basis of a broad set of
health risk measures and information'' and that the ``judgment on
acceptability cannot be reduced to any single factor.'' Benzene NESHAP
at 38046. The determination of what represents an ``acceptable'' risk
is based on a judgment of ``what risks are acceptable in the world in
which we live'' (Risk Report at 178, quoting NRDC v. EPA, 824 F.2d
1146, 1165 (D.C. Cir. 1987) (en banc) (``Vinyl Chloride''), recognizing
that our world is not risk-free.
In the Benzene NESHAP, we stated that ``EPA will generally presume
that if the risk to [the maximum exposed] individual is no higher than
approximately one in 10 thousand, that risk level is considered
acceptable.'' 54 FR at 38045, September 14, 1989. We discussed the
maximum individual lifetime cancer risk (or maximum individual risk
(MIR)) as being ``the estimated risk that a person living near a plant
would have if he or she were exposed to the maximum pollutant
concentrations for 70 years.'' Id. We explained that this measure of
risk ``is an estimate of the upper bound of risk based on conservative
assumptions, such as continuous exposure for 24 hours per day for 70
years.'' Id. We acknowledged that maximum individual lifetime cancer
risk ``does not necessarily reflect the true risk, but displays a
conservative risk level which is an upper-bound that is unlikely to be
exceeded.'' Id.
Understanding that there are both benefits and limitations to using
the MIR as a metric for determining acceptability, we acknowledged in
the Benzene NESHAP that ``consideration of maximum individual risk * *
* must take into account the strengths and weaknesses of this measure
of risk.'' Id. Consequently, the presumptive risk level of 100-in-1
million (1-in-10 thousand) provides a benchmark for judging the
acceptability of maximum individual lifetime cancer risk, but does not
constitute a rigid line for making that determination. Further, in the
Benzene NESHAP, we noted that:
``[p]articular attention will also be accorded to the weight of
evidence presented in the risk assessment of potential
carcinogenicity or other health effects of a pollutant. While the
same numerical risk may be estimated for an exposure to a pollutant
judged to be a known human carcinogen, and to a pollutant considered
a possible human carcinogen based on limited animal test data, the
same weight cannot be accorded to both estimates. In considering the
potential public health effects of the two pollutants, the Agency's
judgment on acceptability, including the MIR, will be influenced by
the greater weight of evidence for the known human carcinogen.''
Id. at 38046. The Agency also explained in the Benzene NESHAP that:
``[i]n establishing a presumption for MIR, rather than a rigid
line for acceptability, the Agency intends to weigh it with a series
of other health measures and factors. These include the overall
incidence of cancer or other serious health effects within the
exposed population, the numbers of persons exposed within each
individual lifetime risk range and associated incidence within,
typically, a 50 kilometers (km) exposure radius around facilities,
the science policy assumptions and estimation uncertainties
associated with the risk measures, weight of the scientific evidence
for human health effects, other quantified or unquantified health
effects, effects due to co-location of facilities, and co-emission
of pollutants.''
Id. at 38045. In some cases, these health measures and factors taken
together may provide a more realistic description of the magnitude of
risk in the exposed population than that provided by maximum individual
lifetime cancer risk alone.
As noted earlier, in NRDC v. EPA, the Court held that CAA section
112(f)(2) ``incorporates the EPA's interpretation of the Clean Air Act
from the Benzene Standard.'' The Court further held that Congress'
incorporation of the Benzene standard applies equally to carcinogens
and non-carcinogens. 529 F.3d at 1081-82. Accordingly, we also consider
non-cancer risk metrics in our determination of risk acceptability and
ample margin of safety.
2. Step 2--Determination of Ample Margin of Safety
CAA section 112(f)(2) requires the EPA to determine, for source
categories
[[Page 95814]]
subject to MACT standards, whether those standards provide an ample
margin of safety to protect public health. As explained in the Benzene
NESHAP, ``the second step of the inquiry, determining an `ample margin
of safety,' again includes consideration of all of the health factors,
and whether to reduce the risks even further. . . . Beyond that
information, additional factors relating to the appropriate level of
control will also be considered, including costs and economic impacts
of controls, technological feasibility, uncertainties, and any other
relevant factors. Considering all of these factors, the agency will
establish the standard at a level that provides an ample margin of
safety to protect the public health, as required by section 112.'' 54
FR 38046, September 14, 1989.
According to CAA section 112(f)(2)(A), if the MACT standards for
HAP ``classified as a known, probable, or possible human carcinogen do
not reduce lifetime excess cancer risks to the individual most exposed
to emissions from a source in the category or subcategory to less than
one in one million,'' the EPA must promulgate residual risk standards
for the source category (or subcategory), as necessary to provide an
ample margin of safety to protect public health. In doing so, the EPA
may adopt standards equal to existing MACT standards if the EPA
determines that the existing standards (i.e., the MACT standards) are
sufficiently protective. NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir.
2008) (``If EPA determines that the existing technology-based standards
provide an 'ample margin of safety,' then the Agency is free to readopt
those standards during the residual risk rulemaking.'') The EPA must
also adopt more stringent standards, if necessary, to prevent an
adverse environmental effect,\1\ but must consider cost, energy,
safety, and other relevant factors in doing so.
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\1\ ``Adverse environmental effect'' is defined as any
significant and widespread adverse effect, which may be reasonably
anticipated to wildlife, aquatic life, or natural resources,
including adverse impacts on populations of endangered or threatened
species or significant degradation of environmental qualities over
broad areas. CAA section 112(a)(7).
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The CAA does not specifically define the terms ``individual most
exposed,'' ``acceptable level,'' and ``ample margin of safety.'' In the
Benzene NESHAP, 54 FR 38044, September 14, 1989, we stated as an
overall objective:
In protecting public health with an ample margin of safety under
section 112, EPA strives to provide maximum feasible protection
against risks to health from hazardous air pollutants by (1)
protecting the greatest number of persons possible to an individual
lifetime risk level no higher than approximately 1-in-1 million and
(2) limiting to no higher than approximately 1-in-10 thousand [i.e.,
100-in-1 million] the estimated risk that a person living near a
plant would have if he or she were exposed to the maximum pollutant
concentrations for 70 years.
The Agency further stated that ``[t]he EPA also considers incidence
(the number of persons estimated to suffer cancer or other serious
health effects as a result of exposure to a pollutant) to be an
important measure of the health risk to the exposed population.
Incidence measures the extent of health risks to the exposed population
as a whole, by providing an estimate of the occurrence of cancer or
other serious health effects in the exposed population.'' Id. at 38045.
In the ample margin of safety decision process, the Agency again
considers all of the health risks and other health information
considered in the first step, including the incremental risk reduction
associated with standards more stringent than the MACT standard or a
more stringent standard that the EPA has determined is necessary to
ensure risk is acceptable. In the ample margin of safety analysis, the
Agency considers additional factors, including costs and economic
impacts of controls, technological feasibility, uncertainties, and any
other relevant factors. Considering all of these factors, the Agency
will establish the standard at a level that provides an ample margin of
safety to protect the public health, as required by CAA section 112(f).
54 FR 38046, September 14, 1989.
B. What is this source category and how does the current NESHAP
regulate its HAP emissions?
In the original 1992 list of sources under CAA section 112(c)(1),
the EPA defined the Baker's Yeast Manufacturing source category as
including any facility engaged in the manufacture of baker's yeast by
fermentation (both active dry yeast and compressed yeast) (57 FR
31576). The EPA explained that the category included, but was not
limited to, the following manufacturing process units: Fermentation
vessels and the drying and packaging system. The original source
category was renamed to Manufacturing of Nutritional Yeast in 1998 to
clarify that the source category covered the manufacturing of yeast,
not its use in facilities such as breweries or bakeries. Both ``baker's
yeast'' and ``nutritional yeast'' are common names for Saccharomyces
cerevisiae, which is a specific species of yeast that is used to
produce many common food and beverage products and whose manufacturing
process typically emits HAP. The 40 CFR part 63, subpart CCCC NESHAP,
which was finalized in 2001, defines a manufacturer of nutritional
yeast as a facility that makes yeast for the purpose of becoming an
ingredient in dough for bread or any other yeast-raised baked product,
or for becoming a nutritional food additive intended for consumption by
humans (66 FR 27876). Facilities that manufacture nutritional yeast
intended for consumption by animals, such as an additive for livestock
feed, are not included in the description of sources covered by this
subpart in 40 CFR 63.2131. In addition, the NESHAP clarifies that
fermenters are not subject to emission limits during the production of
specialty yeast (e.g., yeast for use in wine, champagne, whiskey, or
beer) in 40 CFR 63.2132. We are not proposing to amend the source
category definition in this action and are, therefore, not seeking
comment on the source category definition at this time.
Only facilities that are located at or are part of a major source
of HAP emissions are subject to the Manufacturing of Nutritional Yeast
NESHAP; area sources of HAP are not subject to the rule. The HAP
emitted by nutritional yeast manufacturing facilities is acetaldehyde,
a probable carcinogen. In 2016, there are four nutritional yeast
manufacturing facilities that are subject to the NESHAP.
The affected sources at nutritional yeast manufacturing facilities
are the collection of equipment used to manufacture Saccharomyces
cerevisiae yeast, including fermenters. The sizes of the fermenters
vary; generally smaller fermenters are used for earlier fermentation
stages and larger fermenters are used for later fermentation stages.
The initial, smaller fermenters, where the sugar source is added only
at the start of the batch (e.g., laboratory and pure culture
fermenters), are not subject to emission limits. The 40 CFR part 63,
subpart CCCC emission limits apply to the final three stages of the
fermentation process where the sugar source is added intermittently
throughout the process, which are often referred to as stock (third-to-
last stage), first generation (second-to-last stage), and trade (last
stage) fermentation.
Currently, the fermenters are subject to batch average VOC emission
limits that differ for each fermentation stage, and which must be met
for 98 percent of all batches in each fermentation stage on a rolling
12-month basis. VOC is used as a surrogate for the HAP of interest,
acetaldehyde. The batch
[[Page 95815]]
average VOC limits are 300 parts per million by volume (ppmv) for stock
fermenters (third-to-last stage), 200 ppmv for first generation
fermenters (second-to-last stage), and 100 ppmv for trade fermenters
(last stage).
In the current NESHAP, facilities can continuously monitor either
the VOC concentration in the fermenter exhaust or the brew ethanol
concentration in the fermenter liquid to determine compliance with the
emission limits. If a facility monitors brew ethanol concentration, it
must conduct an annual performance test to determine the correlation
between the brew ethanol concentration in the fermenter liquid and the
VOC concentration in the fermenter exhaust gas.
C. What data collection activities were conducted to support this
action?
The EPA visited three nutritional yeast manufacturing facilities
during the development of the NESHAP. Those facilities were the
American Yeast and AB Mauri Fleischmann's Yeast facilities in Memphis,
Tennessee, which we visited in December 2015, and the Red Star Yeast
facility in Cedar Rapids, Iowa, which we visited in June 2016. We also
held a conference call with the Minn-Dak Wahpeton facility, located in
Wahpeton, North Dakota, in May 2016. The EPA discussed the specific
yeast fermentation processes employed by each facility, including a
discussion of the number and design of their fermenters and associated
emission points, the process controls and monitors used, unregulated
emission sources, and other aspects of facility operations. The site
visits and conference call are documented in separate memoranda: ``Site
Visit Report--American Yeast Corporation, Memphis Plant,'' ``Site Visit
Report--AB Mauri Fleischmann's Yeast, Memphis Plant,'' ``Site Visit
Report--Red Star Yeast, Cedar Rapids, IA,'' and ``Notes from May 6,
2016 Conference Call Between the EPA and Minn-Dak Wahpeton,'' which are
available in the docket for this action.
D. What other relevant background information and data are available?
The EPA used information from the National Emissions Inventory
(NEI) and the RACT/BACT/LAER Clearinghouse (RBLC) to support this
proposed rulemaking. We used the NEI emissions and supporting data to
develop the modeling file for the risk review. The EPA utilized the
RBLC to identify additional control technologies for the technology
review. See sections III.A, III.C, and IV.C of this preamble for
further details on the use of these sources of information.
III. Analytical Procedures
In this section, we describe the analyses performed to support the
proposed decisions for the RTR and other issues addressed in this
proposal.
A. How did we estimate post-MACT risks posed by the source category?
The EPA conducted a risk assessment that provides estimates of the
MIR posed by the HAP emissions from each source in the source category,
the hazard index (HI) for chronic exposures to HAP with the potential
to cause non-cancer health effects, and the hazard quotient (HQ) for
acute exposures to HAP with the potential to cause non-cancer health
effects. The assessment also provides estimates of the distribution of
cancer risks within the exposed populations, cancer incidence, and an
evaluation of the potential for adverse environmental effects. The
eight sections that follow this paragraph describe how we estimated
emissions and conducted the risk assessment. The docket for this
rulemaking contains the following document which provides more
information on the risk assessment inputs and models: ``Residual Risk
Assessment for the Manufacturing of Nutritional Yeast Source Category
in Support of the December 2016 Risk and Technology Review Proposed
Rule.'' The methods used to assess risks (as described in the eight
primary steps below) are consistent with those peer-reviewed by a panel
of the EPA's Science Advisory Board (SAB) in 2009 and described in
their peer review report issued in 2010; \2\ they are also consistent
with the key recommendations contained in that report.
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\2\ U.S. EPA SAB. Risk and Technology Review (RTR) Risk
Assessment Methodologies: For Review by the EPA's Science Advisory
Board with Case Studies--MACT I Petroleum Refining Sources and
Portland Cement Manufacturing, May 2010.
---------------------------------------------------------------------------
1. How did we estimate actual emissions and identify the emissions
release characteristics?
Fermenters are the primary emission source at nutritional yeast
facilities. Each fermenter emission source has a stack through which
the emissions are vented. The HAP emitted is acetaldehyde, which is a
by-product of the fermentation process. We used acetaldehyde emissions
data from the 2011 NEI and state emission reports (i.e., Iowa Emissions
Inventory Questionnaire reports) as the basis of the actual emission
estimates for each facility. The stack parameters used for each
fermenter were obtained from the 2011 NEI, title V permits, or were
provided to the Agency during site visits. We used default parameters
if site-specific information was not available. Additional details on
the data and methods used to develop actual emissions for the risk
modeling are provided in the memorandum, ``Emissions Data and Acute
Risk Factor Used in Residual Risk Modeling: Manufacturing of
Nutritional Yeast Source Category,'' which is available in the docket
for this action.
2. How did we estimate MACT-allowable emissions?
The available emissions data in the RTR emissions dataset include
estimates of the mass of HAP emitted during the specified annual time
period. In some cases, these ``actual'' emission levels are lower than
the emission levels required to comply with the current MACT standards.
The emissions level allowed to be emitted by the MACT standards is
referred to as the ``MACT-allowable'' emissions level. We discussed the
use of both MACT-allowable and actual emissions in the final Coke Oven
Batteries RTR (70 FR 19998-19999, April 15, 2005) and in the proposed
and final Hazardous Organic NESHAP RTRs (71 FR 34428, June 14, 2006,
and 71 FR 76609, December 21, 2006, respectively). In those actions, we
noted that assessing the risks at the MACT-allowable level is
inherently reasonable since these risks reflect the maximum level
facilities could emit and still comply with national emission
standards. We also explained that it is reasonable to consider actual
emissions, where such data are available, in both steps of the risk
analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044,
September 14, 1989.)
For nutritional yeast manufacturing facilities, we used the actual
emissions as the basis for the MACT-allowable emissions in the risk
assessment. We set allowable emissions equal to actual emissions based
on information gathered during the site visits that the facilities are
operating near maximum capacity and close to the level of emissions
allowed under the NESHAP. It is difficult to calculate a precise
allowable emissions level for this industry because the emission limits
are based on the average emissions concentration during each batch and
the absolute number of batches produced at a facility fluctuates each
year based on market demand for yeast.
Furthermore, facilities are also unlikely to emit significantly
higher levels of HAP due to a business incentive to minimize
acetaldehyde
[[Page 95816]]
emissions and continuous monitoring requirements in the rule.
Acetaldehyde is a by-product of sub-optimal yeast production.
Increasing concentrations of acetaldehyde indicate decreases relative
to the potential amount and/or quality of yeast that can be produced
within a fermentation batch, resulting in a loss of profit for the
yeast manufacturer. Therefore, companies have a business incentive to
reduce HAP emissions as much as possible. Additionally, continuous
monitoring ensures that the facilities receive real-time information
about emissions throughout the yeast manufacturing process. These
monitoring systems have enabled facilities to set up control systems
that automatically adjust process parameters in real-time to reduce
emissions if they reach a specified level.
As stated above, MACT-allowable emissions are used to develop
estimates of risk when actual emissions are lower than those required
to meet current emission standards. Due to the difficulties that limit
the calculation of allowable emissions (e.g., the current NESHAP
standard requirements) and the low likelihood of facilities emitting
significantly higher levels of HAP than current amounts, actual
emissions provide the most accurate estimate of emissions that will be
emitted from nutritional yeast manufacturing facilities. Therefore, we
determined that the use of actual emissions as the basis of the MACT-
allowable emissions in this risk assessment is the most appropriate
option for this subpart.
3. How did we conduct dispersion modeling, determine inhalation
exposures, and estimate individual and population inhalation risks?
Both long-term and short-term inhalation exposure concentrations
and health risks from the source category addressed in this proposal
were estimated using the Human Exposure Model (Community and Sector
HEM-3 version 1.1.0). The HEM-3 performs three primary risk assessment
activities: (1) Conducting dispersion modeling to estimate the
concentrations of HAP in ambient air, (2) estimating long-term and
short-term inhalation exposures to individuals residing within 50 km of
the modeled sources,\3\ and (3) estimating individual and population-
level inhalation risks using the exposure estimates and quantitative
dose-response information.
---------------------------------------------------------------------------
\3\ This metric comes from the Benzene NESHAP. See 54 FR 38046.
---------------------------------------------------------------------------
The air dispersion model used by the HEM-3 model (AERMOD) is one of
the EPA's preferred models for assessing pollutant concentrations from
industrial facilities.\4\ To perform the dispersion modeling and to
develop the preliminary risk estimates, HEM-3 draws on three data
libraries. The first is a library of meteorological data, which is used
for dispersion calculations. This library includes 1 year (2014) of
hourly surface and upper air observations for more than 800
meteorological stations, selected to provide coverage of the United
States and Puerto Rico. A second library of United States Census Bureau
census block \5\ internal point locations and populations provides the
basis of human exposure calculations (U.S. Census, 2010). In addition,
for each census block, the census library includes the elevation and
controlling hill height, which are also used in dispersion
calculations. A third library of pollutant unit risk factors and other
health benchmarks is used to estimate health risks. These risk factors
and health benchmarks are the latest values recommended by the EPA for
HAP and other toxic air pollutants. These values are available at
https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants and are discussed in
more detail later in this section.
---------------------------------------------------------------------------
\4\ U.S. EPA. Revision to the ``Guideline on Air Quality Models:
Adoption of a Preferred General Purpose (Flat and Complex Terrain)
Dispersion Model and Other Revisions'' (70 FR 68218, November 9,
2005).
\5\ A census block is the smallest geographic area for which
census statistics are tabulated.
---------------------------------------------------------------------------
In developing the risk assessment for chronic exposures, we used
the estimated annual average ambient air concentrations of each HAP
emitted by each source for which we have emissions data in the source
category. The air concentrations at each nearby census block centroid
were used as a surrogate for the chronic inhalation exposure
concentration for all the people who reside in that census block. We
calculated the MIR for each facility as the cancer risk associated with
a continuous lifetime (24 hours per day, 7 days per week, and 52 weeks
per year for a 70-year period) exposure to the maximum concentration at
the centroid of inhabited census blocks. Individual cancer risks were
calculated by multiplying the estimated lifetime exposure to the
ambient concentration of each of the HAP (in micrograms per cubic meter
([mu]g/m\3\)) by its unit risk estimate (URE). The URE is an upper
bound estimate of an individual's probability of contracting cancer
over a lifetime of exposure to a concentration of 1 microgram of the
pollutant per cubic meter of air. For residual risk assessments, we
generally use URE values from the EPA's Integrated Risk Information
System (IRIS). For carcinogenic pollutants without IRIS values, we look
to other reputable sources of cancer dose-response values, often using
California EPA (CalEPA) URE values, where available. In cases where
new, scientifically credible dose response values have been developed
in a manner consistent with the EPA guidelines and have undergone a
peer review process similar to that used by the EPA, we may use such
dose-response values in place of, or in addition to, other values, if
appropriate.
The EPA estimated incremental individual lifetime cancer risks
associated with emissions from the facilities in the source category as
the sum of the risks for each of the carcinogenic HAP (including those
classified as carcinogenic to humans, likely to be carcinogenic to
humans, and suggestive evidence of carcinogenic potential) \6\ emitted
by the modeled sources. Cancer incidence and the distribution of
individual cancer risks for the population within 50 km of the sources
were also estimated for the source category as part of this assessment
by summing individual risks. A distance of 50 km is consistent with
both the analysis supporting the 1989 Benzene NESHAP (54 FR 38044,
September 14, 1989) and the limitations of Gaussian dispersion models,
including AERMOD.
---------------------------------------------------------------------------
\6\ These classifications also coincide with the terms ``known
carcinogen, probable carcinogen, and possible carcinogen,''
respectively, which are the terms advocated in the EPA's previous
``Guidelines for Carcinogen Risk Assessment,'' published in 1986 (51
FR 33992, September 24, 1986). Summing the risks of these individual
compounds to obtain the cumulative cancer risks is an approach that
was recommended by the EPA's SAB in their 2002 peer review of the
EPA's National Air Toxics Assessment (NATA) titled, ``NATA--
Evaluating the National-scale Air Toxics Assessment 1996 Data--an
SAB Advisory,'' available at http://yosemite.epa.gov/sab/
sabproduct.nsf/214C6E915BB04E14852570CA007A682C/$File/
ecadv02001.pdf.
---------------------------------------------------------------------------
To assess the risk of non-cancer health effects from chronic
exposures, we summed the HQ for each of the HAP that affects a common
target organ system to obtain the HI for that target organ system (or
target organ-specific HI, TOSHI). The HQ is the estimated exposure
divided by the chronic reference value, which is a value selected from
one of several sources. First, the chronic reference level can be the
EPA reference concentration (RfC) (https://ofmpub.epa.gov/sor_internet/
registry/termreg/searchandretrieve/glossariesandkeywordlists/
search.do?details=&glossaryName=Risk
[[Page 95817]]
%20Assessment%20Glossary), defined as ``an estimate (with uncertainty
spanning perhaps an order of magnitude) of a continuous inhalation
exposure to the human population (including sensitive subgroups) that
is likely to be without an appreciable risk of deleterious effects
during a lifetime.'' Alternatively, in cases where an RfC from the
EPA's IRIS database is not available or where the EPA determines that
using a value other than the RfC is appropriate, the chronic reference
level can be a value from the following prioritized sources: (1) The
Agency for Toxic Substances and Disease Registry Minimum Risk Level
(http://www.atsdr.cdc.gov/mrls/index.asp), which is defined as ``an
estimate of daily human exposure to a hazardous substance that is
likely to be without an appreciable risk of adverse non-cancer health
effects (other than cancer) over a specified duration of exposure'';
(2) the CalEPA Chronic Reference Exposure Level (REL) (http://oehha.ca.gov/media/downloads/crnr/2015guidancemanual.pdf), which is
defined as ``the concentration level (that is expressed in units of
micrograms per cubic meter ([mu]g/m\3\) for inhalation exposure and in
a dose expressed in units of milligram per kilogram-day (mg/kg-day) for
oral exposures), at or below which no adverse health effects are
anticipated for a specified exposure duration''; or (3), as noted
above, a scientifically credible dose-response value that has been
developed in a manner consistent with the EPA guidelines and has
undergone a peer review process similar to that used by the EPA, in
place of or in concert with other values.
As mentioned above, in order to characterize non-cancer chronic
effects, and in response to key recommendations from the SAB, the EPA
selects dose-response values that reflect the best available science
for all HAP included in RTR risk assessments.\7\ More specifically, for
a given HAP, the EPA examines the availability of inhalation reference
values from the sources included in our tiered approach (e.g., IRIS
first, Agency for Toxic Substances and Disease Registry (ATSDR) second,
CalEPA third) and determines which inhalation reference value
represents the best available science. Thus, as new inhalation
reference values become available, the EPA will typically evaluate them
and determine whether they should be given preference over those
currently being used in RTR risk assessments.
---------------------------------------------------------------------------
\7\ The SAB peer review of RTR Risk Assessment Methodologies is
available at http://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
---------------------------------------------------------------------------
The EPA also evaluated screening estimates of acute exposures and
risks for each of the HAP (for which appropriate acute dose-response
values are available) at the point of highest potential off-site
exposure for each facility. To do this, the EPA estimated the risks
when both the peak hourly emissions rate and worst-case dispersion
conditions occur. We also assume that a person is located at the point
of highest impact during that same time. In accordance with our mandate
in section 112 of the CAA, we use the point of highest off-site
exposure to assess the potential risk to the maximally exposed
individual. The acute HQ is the estimated acute exposure divided by the
acute dose-response value. In each case, the EPA calculated acute HQ
values using best available, short-term dose-response values. These
acute dose-response values, which are described below, include the
acute REL, acute exposure guideline levels (AEGL) and emergency
response planning guidelines (ERPG) for 1-hour exposure durations. As
discussed below, we used conservative assumptions for emissions rates,
meteorology, and exposure location.
As described in the CalEPA's ``Air Toxics Hot Spots Program Risk
Assessment Guidelines, Part I, The Determination of Acute Reference
Exposure Levels for Airborne Toxicants,'' an acute REL value (http://oehha.ca.gov/media/downloads/crnr/acuterel.pdf) is defined as ``the
concentration level at or below which no adverse health effects are
anticipated for a specified exposure duration.'' Id. at page 2. Acute
REL values are based on the most sensitive, relevant, adverse health
effect reported in the peer-reviewed medical and toxicological
literature. Acute REL values are designed to protect the most sensitive
individuals in the population through the inclusion of margins of
safety. Because margins of safety are incorporated to address data gaps
and uncertainties, exceeding the REL does not automatically indicate an
adverse health impact.
AEGL values were derived in response to recommendations from the
National Research Council (NRC). As described in ``Standing Operating
Procedures (SOP) of the National Advisory Committee on Acute Exposure
Guideline Levels for Hazardous Substances'' (https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf),\8\ ``the NRC's
previous name for acute exposure levels--community emergency exposure
levels was replaced by the term AEGL to reflect the broad application
of these values to planning, response, and prevention in the community,
the workplace, transportation, the military, and the remediation of
Superfund sites.'' Id. at 2. This document also states that AEGL values
``represent threshold exposure limits for the general public and are
applicable to emergency exposures ranging from 10 minutes to eight
hours.'' Id. at 2.
---------------------------------------------------------------------------
\8\ National Academy of Sciences (NAS), 2001. Standing Operating
Procedures for Developing Acute Exposure Levels for Hazardous
Chemicals, page 2.
---------------------------------------------------------------------------
The document lays out the purpose and objectives of AEGL by stating
that ``the primary purpose of the AEGL program and the National
Advisory Committee for Acute Exposure Guideline Levels for Hazardous
Substances is to develop guideline levels for once-in-a-lifetime,
short-term exposures to airborne concentrations of acutely toxic, high-
priority chemicals.'' Id. at 21. In detailing the intended application
of AEGL values, the document states that ``[i]t is anticipated that the
AEGL values will be used for regulatory and nonregulatory purposes by
U.S. Federal and state agencies and possibly the international
community in conjunction with chemical emergency response, planning,
and prevention programs. More specifically, the AEGL values will be
used for conducting various risk assessments to aid in the development
of emergency preparedness and prevention plans, as well as real-time
emergency response actions, for accidental chemical releases at fixed
facilities and from transport carriers.'' Id. at 31.
The AEGL-1 value is then specifically defined as ``the airborne
concentration (expressed as ppm (parts per million) or mg/m\3\
(milligrams per cubic meter)) of a substance above which it is
predicted that the general population, including susceptible
individuals, could experience notable discomfort, irritation, or
certain asymptomatic nonsensory effects. However, the effects are not
disabling and are transient and reversible upon cessation of
exposure.'' Id. at 3. The document also notes that, ``Airborne
concentrations below AEGL-1 represent exposure levels that can produce
mild and progressively increasing but transient and nondisabling odor,
taste, and sensory irritation or certain asymptomatic, nonsensory
effects.'' Id. Similarly, the document defines AEGL-2 values as
[[Page 95818]]
``the airborne concentration (expressed as parts per million or
milligrams per cubic meter) of a substance above which it is predicted
that the general population, including susceptible individuals, could
experience irreversible or other serious, long-lasting adverse health
effects or an impaired ability to escape.'' Id.
ERPG values are derived for use in emergency response, as described
in the American Industrial Hygiene Association's ERP Committee document
titled, ``ERPGS Procedures and Responsibilities'' (https://www.aiha.org/get-involved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Documents/ERPG%20Committee%20Standard%20Operating%20Procedures%20%20-%20March%202014%20Revision%20%28Updated%2010-2-2014%29.pdf), which
states that, ``Emergency Response Planning Guidelines were developed
for emergency planning and are intended as health based guideline
concentrations for single exposures to chemicals.'' \9\ Id. at 1. The
ERPG-1 value is defined as ``the maximum airborne concentration below
which it is believed that nearly all individuals could be exposed for
up to 1 hour without experiencing other than mild transient adverse
health effects or without perceiving a clearly defined, objectionable
odor.'' Id. at 2. Similarly, the ERPG-2 value is defined as ``the
maximum airborne concentration below which it is believed that nearly
all individuals could be exposed for up to one hour without
experiencing or developing irreversible or other serious health effects
or symptoms which could impair an individual's ability to take
protective action.'' Id. at 1.
---------------------------------------------------------------------------
\9\ ERP Committee Procedures and Responsibilities. March 2014.
American Industrial Hygiene Association.
---------------------------------------------------------------------------
As can be seen from the definitions above, the AEGL and ERPG values
include the similarly-defined severity levels 1 and 2. For many
chemicals, a severity level 1 value AEGL or ERPG has not been developed
because the types of effects for these chemicals are not consistent
with the AEGL-1/ERPG-1 definitions; in these instances, we compare
higher severity level AEGL-2 or ERPG-2 values to our modeled exposure
levels to screen for potential acute concerns. When AEGL-1/ERPG-1
values are available, they are used in our acute risk assessments.
Acute REL values for 1-hour exposure durations are typically lower
than their corresponding AEGL-1 and ERPG-1 values. Even though their
definitions are slightly different, AEGL-1 values are often the same as
the corresponding ERPG-1 values, and AEGL-2 values are often equal to
ERPG-2 values. Maximum HQ values from our acute screening risk
assessments typically result when basing them on the acute REL value
for a particular pollutant. In cases where our maximum acute HQ value
exceeds 1, we also report the HQ value based on the next highest acute
dose-response value (usually the AEGL-1 and/or the ERPG-1 value).
To develop screening estimates of acute exposures in the absence of
hourly emissions data, generally we first develop estimates of maximum
hourly emissions rates by multiplying the average actual annual hourly
emissions rates by a default factor to cover routinely variable
emissions. We choose the factor to use partially based on process
knowledge and engineering judgment. The factor chosen also reflects a
Texas study of short-term emissions variability, which showed that most
peak emission events in a heavily-industrialized four-county area
(Harris, Galveston, Chambers, and Brazoria Counties, Texas) were less
than twice the annual average hourly emissions rate. The highest peak
emissions event was 74 times the annual average hourly emissions rate,
and the 99th percentile ratio of peak hourly emissions rate to the
annual average hourly emissions rate was 9.\10\ Considering this
analysis, to account for more than 99 percent of the peak hourly
emissions, we apply a conservative screening multiplication factor of
10 to the average annual hourly emissions rate in our acute exposure
screening assessments as our default approach. However, we use a factor
other than 10 if we have information that indicates that a different
factor is appropriate for a particular source category.
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\10\ Allen, et al., Variable Industrial VOC Emissions and their
impact on ozone formation in the Houston Galveston Area. Texas
Environmental Research Consortium, 2004, and available online at:
https://www.researchgate.net/publication/237593060_Variable_Industrial_VOC_Emissions
and_their_Impact_on_Ozone_Formation_in_the_Houston_Galveston_Area
---------------------------------------------------------------------------
For this source category, we used an acute multiplication factor of
1.2 for all emission sources from nutritional yeast manufacturing
facilities. The factor equals the average peak-to-mean ratio developed
using 5 years of batch-averaged fermenter VOC concentration data from
the facility with the highest emissions in the 2011 NEI. While the
current rule requires continuous monitoring of emissions, facilities
are required to report whether the percentage of batches that meet
emission limits based on the average concentration of VOC emitted from
each batch meets the current compliance requirements; not the
continuous levels of emissions at the facility. Using the data above,
we developed a multiplier to estimate potential acute emissions from
each facility in this source category. A further discussion of why this
factor was chosen can be found in the memorandum, ``Emissions Data and
Acute Risk Factor Used in Residual Risk Modeling: Manufacturing of
Nutritional Yeast Source Category,'' available in the docket for this
rulemaking.
As part of our acute risk assessment process, for cases where acute
HQ values from the screening step were less than or equal to 1 (even
under the conservative assumptions of the screening analysis), acute
impacts were deemed negligible and no further analysis was performed
for these HAP. In cases where an acute HQ from the screening step was
greater than 1, additional site-specific data were considered to
develop a more refined estimate of the potential for acute impacts of
concern. For this source category, all acute HQ screening values were
less than 1. Therefore, we did not employ additional data refinements.
Ideally, we would prefer to have continuous measurements over time
to see how the emissions vary by each hour over an entire year. Having
a frequency distribution of hourly emissions rates over a year would
allow us to perform a probabilistic analysis to estimate potential
threshold exceedances and their frequency of occurrence. Such an
evaluation could include a more complete statistical treatment of the
key parameters and elements adopted in this screening analysis.
Recognizing that this level of data is rarely available, we instead
rely on the multiplier approach.
To better characterize the potential health risks associated with
estimated acute exposures to HAP, and in response to a key
recommendation from the SAB's peer review of the EPA's RTR risk
assessment methodologies,\11\ we generally examine a wider range of
available acute health metrics (e.g., RELs, AEGLs) than we do for our
chronic risk assessments. This is in response to the SAB's
acknowledgement that there are generally more data gaps and
inconsistencies in acute reference values than there are in chronic
reference values. In some cases, when
[[Page 95819]]
Reference Value Arrays \12\ for HAP have been developed, we consider
additional acute values (i.e., occupational and international values)
to provide a more complete risk characterization.
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\11\ The SAB peer review of RTR Risk Assessment Methodologies is
available at http://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
\12\ U.S. EPA. Chapter 2.9, Chemical Specific Reference Values
for Formaldehyde in Graphical Arrays of Chemical-Specific Health
Effect Reference Values for Inhalation Exposures (Final Report).
U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/
061, 2009, and available online at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=211003.
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4. How did we conduct the multi-pathway exposure and risk screening?
The EPA conducted a screening analysis examining the potential for
significant human health risks due to exposures via routes other than
inhalation (i.e., ingestion). We first determined whether any sources
in the source category emitted any HAP known to be persistent and
bioaccumulative in the environment (PB-HAP). The PB-HAP compounds or
compound classes are identified for the screening from the EPA's Air
Toxics Risk Assessment Library (available at http://www2.epa.gov/fera/risk-assessment-and-modeling-air-toxics-risk-assessment-reference-library).
For the Manufacturing of Nutritional Yeast source category, we did
not identify emissions of any PB-HAP. Because we did not identify PB-
HAP emissions, no further evaluation of multi-pathway risk was
conducted for this source category.
5. How did we assess risks considering emissions control options?
The proposed rule amendments include changes to the form of the
current emission limits, additional testing requirements, changes to
the current monitoring requirements, and updates to the reporting and
recordkeeping requirements. The proposed amendments to the emission
limits may lead to a slight decrease in the overall emissions from the
facilities, but we are unable to quantify this reduction. Facilities
will continue to employ current process controls to comply with the
emission limits (i.e., they are not required to install additional
control technologies); however, the facilities may need to make minor
adjustments to the level of process controls to comply with the new
limits.
The proposed amendments to testing and monitoring requirements will
increase the reliability of the emissions data that is monitored by
each facility to ensure that the current emission limits are being met
consistently. Therefore, risks considering the proposed amendments are
estimated to be the same as actual risks under the current MACT
standard.
6. How did we conduct the environmental risk screening assessment?
a. Adverse Environmental Effect
The EPA conducts a screening assessment to examine the potential
for adverse environmental effects as required under section
112(f)(2)(A) of the CAA. Section 112(a)(7) of the CAA defines ``adverse
environmental effect'' as ``any significant and widespread adverse
effect, which may reasonably be anticipated, to wildlife, aquatic life,
or other natural resources, including adverse impacts on populations of
endangered or threatened species or significant degradation of
environmental quality over broad areas.''
b. Environmental HAP
The EPA focuses on seven HAP, which we refer to as ``environmental
HAP,'' in its screening analysis: Five PB-HAP and two acid gases. The
five PB-HAP are cadmium, dioxins/furans, polycyclic organic matter
(POM), mercury (both inorganic mercury and methyl mercury), and lead
compounds. The two acid gases are hydrogen chloride (HCl) and hydrogen
fluoride (HF). The rationale for including these seven HAP in the
environmental risk screening analysis is presented below.
HAP that persist and bioaccumulate are of particular environmental
concern because they accumulate in the soil, sediment, and water. The
PB-HAP are taken up, through sediment, soil, water, and/or ingestion of
other organisms, by plants or animals (e.g., small fish) at the bottom
of the food chain. As larger and larger predators consume these
organisms, concentrations of the PB-HAP in the animal tissues increases
as does the potential for adverse effects. The five PB-HAP we evaluate
as part of our screening analysis account for 99.8 percent of all PB-
HAP emissions nationally from stationary sources (on a mass basis from
the 2005 NEI.
In addition to accounting for almost all of the mass of PB-HAP
emitted, we note that the TRIM.FaTE model that we use to evaluate
multi-pathway risk allows us to estimate concentrations of cadmium
compounds, dioxins/furans, POM, and mercury in soil, sediment and
water. For lead compounds, we currently do not have the ability to
calculate these concentrations using the TRIM.FaTE model. Therefore, to
evaluate the potential for adverse environmental effects from lead
compounds, we compare the estimated HEM-modeled exposures from the
source category emissions of lead with the level of the secondary
National Ambient Air Quality Standards (NAAQS) for lead.\13\ We
consider values below the level of the secondary lead NAAQS to be
unlikely to cause adverse environmental effects.
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\13\ The secondary lead NAAQS is a reasonable measure of
determining whether there is an adverse environmental effect since
it was established considering ``effects on soils, water, crops,
vegetation, man-made materials, animals, wildlife, weather,
visibility and climate, damage to and deterioration of property, and
hazards to transportation, as well as effects on economic values and
on personal comfort and well-being.''
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Due to their well-documented potential to cause direct damage to
terrestrial plants, we include two acid gases, HCl, and HF in the
environmental screening analysis. According to the 2005 NEI, HCl, and
HF account for about 99 percent (on a mass basis) of the total acid gas
HAP emitted by stationary sources in the U.S. In addition to the
potential to cause direct damage to plants, high concentrations of HF
in the air have been linked to fluorosis in livestock. Air
concentrations of these HAP are already calculated as part of the human
multi-pathway exposure and risk screening analysis using the HEM3-
AERMOD air dispersion model, and we are able to use the air dispersion
modeling results to estimate the potential for an adverse environmental
effect.
The EPA acknowledges that other HAP beyond the seven HAP discussed
above may have the potential to cause adverse environmental effects.
Therefore, the EPA may include other relevant HAP in its environmental
risk screening in the future, as modeling science and resources allow.
The EPA invites comment on the extent to which other HAP emitted by the
source category may cause adverse environmental effects. Such
information should include references to peer-reviewed ecological
effects benchmarks that are of sufficient quality for making regulatory
decisions, as well as information on the presence of organisms located
near facilities within the source category that such benchmarks
indicate could be adversely affected.
c. Screening Methodology
For the environmental risk screening analysis, the EPA first
determined whether any facilities in the Manufacturing of Nutritional
Yeast source category emitted any of the seven environmental HAP. For
this source category, we did not identify emissions
[[Page 95820]]
of any of the seven environmental HAP included in the screen. Because
we did not identify environmental HAP emissions, we did not conduct a
further evaluation of environmental risk.
7. How did we conduct facility-wide assessments?
To put the source category risks in context, we typically examine
the risks from the entire ``facility,'' where the facility includes all
HAP-emitting operations within a contiguous area and under common
control. In other words, we examine the HAP emissions not only from the
source category emission points of interest, but also emissions of HAP
from all other emission sources at the facility for which we have data.
The current NESHAP does not set emission limits for equipment other
than fermenters at the affected sources. There is a potential for
temporary wastewater storage tanks (e.g., pH adjustment tanks) and
dryers to emit small amounts of acetaldehyde at nutritional yeast
facilities covered by this subpart. The NEI does not include emissions
from wastewater storage tanks at any of the four facilities subject to
this rule. Only one of the four facilities has dryers; the NEI did
report estimated emissions from these dryers, which were included in
the risk assessment for this source category.
We did not perform a separate facility-wide risk assessment for
facilities that manufacture nutritional yeast. One facility (American
Yeast) reported 43 pounds of additional HAP emissions, composed largely
of hexane and formaldehyde, from equipment sources not covered by 40
CFR part 63, subpart CCCC (e.g., boilers, equipment covered by other
NESHAP).\14\ However, because these emissions were so low and from
pollutants with low risk factors, we concluded that a facility-wide
risk assessment would yield the same or only very slightly different
results as the source category assessment.
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\14\ Because these emissions originate from sources outside the
manufacturing of nutritional yeast source category, they were also
excluded from the source category risk analysis.
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8. How did we consider uncertainties in risk assessment?
In the Benzene NESHAP, we concluded that risk estimation
uncertainty should be considered in our decision-making under the ample
margin of safety framework. Uncertainty and the potential for bias are
inherent in all risk assessments, including those performed for this
proposal. Although uncertainty exists, we believe that our approach,
which used conservative tools and assumptions, ensures that our
decisions are health protective and environmentally protective. A brief
discussion of the uncertainties in the RTR emissions dataset,
dispersion modeling, inhalation exposure estimates, and dose-response
relationships follows below. A more thorough discussion of these
uncertainties is included in the ``Residual Risk Assessment for the
Manufacturing of Nutritional Yeast Source Category in Support of the
December 2016 Risk and Technology Review Proposed Rule,'' which is
available in the docket for this action.
a. Uncertainties in the RTR Emissions Dataset
Although the development of the RTR emissions dataset involved
quality assurance/quality control processes, the accuracy of emissions
values will vary depending on the source of the data, the degree to
which data are incomplete or missing, the degree to which assumptions
made to complete the datasets are accurate, errors in emission
estimates, and other factors. The emission estimates considered in this
analysis generally are annual totals for certain years, and they do not
reflect short-term fluctuations during the course of a year or
variations from year to year. The estimates of peak hourly emission
rates for the acute effects screening assessment were based on an
emission adjustment factor applied to the average annual hourly
emission rates, which are intended to account for emission fluctuations
due to normal facility operations.
b. Uncertainties in Dispersion Modeling
We recognize there is uncertainty in ambient concentration
estimates associated with any model, including the EPA's recommended
regulatory dispersion model, AERMOD. In using a model to estimate
ambient pollutant concentrations, the user chooses certain options to
apply. For RTR assessments, we select some model options that have the
potential to overestimate ambient air concentrations (e.g., not
including plume depletion or pollutant transformation). We select other
model options that have the potential to underestimate ambient impacts
(e.g., not including building downwash). Other options that we select
have the potential to either under- or overestimate ambient levels
(e.g., meteorology and receptor locations). On balance, considering the
directional nature of the uncertainties commonly present in ambient
concentrations estimated by dispersion models, the approach we apply in
the RTR assessments should yield unbiased estimates of ambient HAP
concentrations.
c. Uncertainties in Inhalation Exposure
The EPA did not include the effects of human mobility on exposures
in the assessment. Specifically, short-term mobility and long-term
mobility between census blocks in the modeling domain were not
considered.\15\ The approach of not considering short or long-term
population mobility does not bias the estimate of the theoretical MIR
(by definition), nor does it affect the estimate of cancer incidence
because the total population number remains the same. It does, however,
affect the shape of the distribution of individual risks across the
affected population, shifting it toward higher estimated individual
risks at the upper end and reducing the number of people estimated to
be at lower risks, thereby increasing the estimated number of people at
specific high risk levels (e.g., 1-in-10 thousand or 1-in-1 million).
---------------------------------------------------------------------------
\15\ Short-term mobility is movement from one micro-environment
to another over the course of hours or days. Long-term mobility is
movement from one residence to another over the course of a
lifetime.
---------------------------------------------------------------------------
In addition, the assessment predicted the chronic exposures at the
centroid of each populated census block as surrogates for the exposure
concentrations for all people living in that block. Using the census
block centroid to predict chronic exposures tends to over-predict
exposures for people in the census block who live farther from the
facility and under-predict exposures for people in the census block who
live closer to the facility. Thus, using the census block centroid to
predict chronic exposures may lead to a potential understatement or
overstatement of the true maximum impact, but is an unbiased estimate
of average risk and incidence. We reduce this uncertainty by analyzing
large census blocks near facilities using aerial imagery and adjusting
the location of the block centroid to better represent the population
in the block, as well as adding additional receptor locations where the
block population is not well represented by a single location.
The assessment evaluates the cancer inhalation risks associated
with pollutant exposures over a 70-year period, which is the assumed
lifetime of an individual. In reality, both the length of time that
modeled emission sources at facilities actually operate (i.e., more or
less than 70 years) and the domestic growth or decline of the modeled
industry (i.e., the increase or decrease in the number or size of
domestic facilities) will influence the future risks
[[Page 95821]]
posed by a given source or source category. Depending on the
characteristics of the industry, these factors will, in most cases,
result in an overestimate both in individual risk levels and in the
total estimated number of cancer cases. However, in the unlikely
scenario where a facility maintains, or even increases, its emissions
levels over a period of more than 70 years, residents live beyond 70
years at the same location, and the residents spend most of their days
at that location, then the cancer inhalation risks could potentially be
underestimated. However, annual cancer incidence estimates from
exposures to emissions from these sources would not be affected by the
length of time an emissions source operates.
The exposure estimates used in these analyses assume chronic
exposures to ambient (outdoor) levels of pollutants. Because most
people spend the majority of their time indoors, actual exposures may
not be as high, depending on the characteristics of the pollutants
modeled. For many of the HAP, indoor levels are roughly equivalent to
ambient levels, but for very reactive pollutants or larger particles,
indoor levels are typically lower. This factor has the potential to
result in an overestimate of 25 to 30 percent of exposures.\16\
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\16\ U.S. EPA. National-Scale Air Toxics Assessment for 1996.
(EPA 453/R-01-003; January 2001; page 85.)
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In addition to the uncertainties highlighted above, there are
several factors specific to the acute exposure assessment that the EPA
conducts as part of the risk review under section 112 of the CAA that
should be highlighted. The accuracy of an acute inhalation exposure
assessment depends on the simultaneous occurrence of independent
factors that may vary greatly, such as hourly emissions rates,
meteorology, and the presence of humans at the location of the maximum
concentration. In the acute screening assessment that we conduct under
the RTR program, we assume that peak emissions from the source category
and worst-case meteorological conditions co-occur, thus, resulting in
maximum ambient concentrations. These two events are unlikely to occur
at the same time, making these assumptions conservative. We then
include the additional assumption that a person is located at this
point during this same time period. For this source category, these
assumptions would tend to be worst-case actual exposures as it is
unlikely that a person would be located at the point of maximum
exposure during the time when peak emissions and worst-case
meteorological conditions occur simultaneously.
d. Uncertainties in Dose-Response Relationships
There are uncertainties inherent in the development of the dose-
response values used in our risk assessments for cancer effects from
chronic exposures and non-cancer effects from both chronic and acute
exposures. Some uncertainties may be considered quantitatively, and
others generally are expressed in qualitative terms. We note as a
preface to this discussion a point on dose-response uncertainty that is
brought out in the EPA's 2005 Cancer Guidelines; namely, that ``the
primary goal of EPA actions is protection of human health; accordingly,
as an Agency policy, risk assessment procedures, including default
options that are used in the absence of scientific data to the
contrary, should be health protective'' (EPA's 2005 Cancer Guidelines,
pages 1-7). This is the approach followed here as summarized in the
next several paragraphs. A complete detailed discussion of
uncertainties and variability in dose-response relationships is given
in the ``Residual Risk Assessment for the Manufacturing of Nutritional
Yeast Source Category in Support of the December 2016 Risk and
Technology Review Proposed Rule,'' which is available in the docket for
this action.
Cancer URE values used in our risk assessments are those that have
been developed to generally provide an upper bound estimate of risk.
That is, they represent a ``plausible upper limit to the true value of
a quantity'' (although this is usually not a true statistical
confidence limit).\17\ In some circumstances, the true risk could be as
low as zero; however, in other circumstances the risk could be
greater.\18\ When developing an upper bound estimate of risk and to
provide risk values that do not underestimate risk, health-protective
default approaches are generally used. To err on the side of ensuring
adequate health protection, the EPA typically uses the upper bound
estimates rather than lower bound or central tendency estimates in our
risk assessments, an approach that may have limitations for other uses
(e.g., priority-setting or expected benefits analysis).
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\17\ IRIS glossary (https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary).
\18\ An exception to this is the URE for benzene, which is
considered to cover a range of values, each end of which is
considered to be equally plausible, and which is based on maximum
likelihood estimates.
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Chronic non-cancer RfC and reference dose (RfD) values represent
chronic exposure levels that are intended to be health-protective
levels. Specifically, these values provide an estimate (with
uncertainty spanning perhaps an order of magnitude) of a continuous
inhalation exposure (RfC) or a daily oral exposure (RfD) to the human
population (including sensitive subgroups) that is likely to be without
an appreciable risk of deleterious effects during a lifetime. To derive
values that are intended to be ``without appreciable risk,'' the
methodology relies upon an uncertainty factor (UF) approach (U.S. EPA,
1993 and 1994), which considers uncertainty, variability, and gaps in
the available data. The UF are applied to derive reference values that
are intended to protect against appreciable risk of deleterious
effects. The UF are commonly default values,\19\ e.g., factors of 10 or
3, used in the absence of compound-specific data; where data are
available, UF may also be developed using compound-specific
information. When data are limited, more assumptions are needed and
more UF are used. Thus, there may be a greater tendency to overestimate
risk in the sense that further study might support development of
reference values that are higher (i.e., less potent) because fewer
default assumptions are needed. However, for some pollutants, it is
possible that risks may be underestimated.
---------------------------------------------------------------------------
\19\ According to the NRC report, ``Science and Judgment in Risk
Assessment'' (NRC, 1994) ``[Default] options are generic approaches,
based on general scientific knowledge and policy judgment, that are
applied to various elements of the risk assessment process when the
correct scientific model is unknown or uncertain.'' The 1983 NRC
report, ``Risk Assessment in the Federal Government: Managing the
Process,'' defined default option as ``the option chosen on the
basis of risk assessment policy that appears to be the best choice
in the absence of data to the contrary'' (NRC, 1983a, p. 63).
Therefore, default options are not rules that bind the Agency;
rather, the Agency may depart from them in evaluating the risks
posed by a specific substance when it believes this to be
appropriate. In keeping with the EPA's goal of protecting public
health and the environment, default assumptions are used to ensure
that risk to chemicals is not underestimated (although defaults are
not intended to overtly overestimate risk). See EPA, ``An
Examination of EPA Risk Assessment Principles and Practices,'' EPA/
100/B-04/001, 2004, available at https://nctc.fws.gov/resources/course-resources/pesticides/Risk%20Assessment/Risk%20Assessment%20Principles%20and%20Practices.pdf.
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While collectively termed ``UF,'' these factors account for a
number of different quantitative considerations when using observed
animal (usually rodent) or human toxicity data in the development of
the RfC. The UF are intended to
[[Page 95822]]
account for: (1) Variation in susceptibility among the members of the
human population (i.e., inter-individual variability); (2) uncertainty
in extrapolating from experimental animal data to humans (i.e.,
interspecies differences); (3) uncertainty in extrapolating from data
obtained in a study with less-than-lifetime exposure (i.e.,
extrapolating from sub-chronic to chronic exposure); (4) uncertainty in
extrapolating the observed data to obtain an estimate of the exposure
associated with no adverse effects; and (5) uncertainty when the
database is incomplete or there are problems with the applicability of
available studies.
Many of the UF used to account for variability and uncertainty in
the development of acute reference values are quite similar to those
developed for chronic durations, but they more often use individual UF
values that may be less than 10. The UF are applied based on chemical-
specific or health effect-specific information (e.g., simple irritation
effects do not vary appreciably between human individuals, hence a
value of 3 is typically used), or based on the purpose for the
reference value (see the following paragraph). The UF applied in acute
reference value derivation include: (1) Heterogeneity among humans; (2)
uncertainty in extrapolating from animals to humans; (3) uncertainty in
lowest observed adverse effect (exposure) level to no observed adverse
effect (exposure) level adjustments; and (4) uncertainty in accounting
for an incomplete database on toxic effects of potential concern.
Additional adjustments are often applied to account for uncertainty in
extrapolation from observations at one exposure duration (e.g., 4
hours) to derive an acute reference value at another exposure duration
(e.g., 1 hour).
Not all acute reference values are developed for the same purpose,
and care must be taken when interpreting the results of an acute
assessment of human health effects relative to the reference value or
values being exceeded. Where relevant to the estimated exposures, the
lack of short-term dose-response values at different levels of severity
should be factored into the risk characterization as potential
uncertainties.
For a group of compounds that are unspeciated (e.g., glycol
ethers), we conservatively use the most protective reference value of
an individual compound in that group to estimate risk. Similarly, for
an individual compound in a group (e.g., ethylene glycol diethyl ether)
that does not have a specified reference value, we also apply the most
protective reference value from the other compounds in the group to
estimate risk.
B. How did we consider the risk results in making decisions for this
proposal?
As discussed in section II.A of this preamble, in evaluating and
developing standards under CAA section 112(f)(2), we apply a two-step
process to address residual risk. In the first step, the EPA determines
whether risks are acceptable. This determination ``considers all health
information, including risk estimation uncertainty, and includes a
presumptive limit on maximum individual lifetime [cancer] risk (MIR)
\20\ of approximately [1-in-10 thousand] [i.e., 100-in-1 million].'' 54
FR 38045, September 14, 1989. If risks are unacceptable, the EPA must
determine the emissions standards necessary to bring risks to an
acceptable level without considering costs. In the second step of the
process, the EPA considers whether the emissions standards provide an
ample margin of safety ``in consideration of all health information,
including the number of persons at risk levels higher than
approximately 1-in-1 million, as well as other relevant factors,
including costs and economic impacts, technological feasibility, and
other factors relevant to each particular decision.'' Id. The EPA must
promulgate emission standards necessary to provide an ample margin of
safety. After conducting the ample margin of safety analysis, we
consider whether a more stringent standard is necessary to prevent,
taking into consideration, costs, energy, safety, and other relevant
factors, an adverse environmental effect.
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\20\ Although defined as ``maximum individual risk,'' MIR refers
only to cancer risk. MIR, one metric for assessing cancer risk, is
the estimated risk were an individual exposed to the maximum level
of a pollutant for a lifetime.
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In past residual risk actions, the EPA considered a number of human
health risk metrics associated with emissions from the categories under
review, including the MIR, the number of persons in various risk
ranges, cancer incidence, the maximum non-cancer HI and the maximum
acute non-cancer hazard. See, e.g., 72 FR 25138, May 3, 2007; and 71 FR
42724, July 27, 2006. The EPA considered this health information for
both actual and allowable emissions. See, e.g., 75 FR 65068, October
21, 2010; 75 FR 80220, December 21, 2010; 76 FR 29032, May 19, 2011.
The EPA also discussed risk estimation uncertainties and considered the
uncertainties in the determination of acceptable risk and ample margin
of safety in these past actions. The EPA considered this same type of
information in support of this action.
The Agency is considering these various measures of health
information to inform our determinations of risk acceptability and
ample margin of safety under CAA section 112(f). As explained in the
Benzene NESHAP, ``the first step judgment on acceptability cannot be
reduced to any single factor'' and, thus, ``[t]he Administrator
believes that the acceptability of risk under [previous] section 112 is
best judged on the basis of a broad set of health risk measures and
information.'' 54 FR 38046, September 14, 1989. Similarly, with regard
to the ample margin of safety determination, ``the Agency again
considers all of the health risk and other health information
considered in the first step. Beyond that information, additional
factors relating to the appropriate level of control will also be
considered, including cost and economic impacts of controls,
technological feasibility, uncertainties, and any other relevant
factors.'' Id.
The Benzene NESHAP approach provides flexibility regarding factors
the EPA may consider in making determinations and how the EPA may weigh
those factors for each source category. In responding to comment on our
policy under the Benzene NESHAP, the EPA explained that:
``[t]he policy chosen by the Administrator permits consideration
of multiple measures of health risk. Not only can the MIR figure be
considered, but also incidence, the presence of non-cancer health
effects, and the uncertainties of the risk estimates. In this way,
the effect on the most exposed individuals can be reviewed as well
as the impact on the general public. These factors can then be
weighed in each individual case. This approach complies with the
Vinyl Chloride mandate that the Administrator ascertain an
acceptable level of risk to the public by employing [her] expertise
to assess available data. It also complies with the Congressional
intent behind the CAA, which did not exclude the use of any
particular measure of public health risk from the EPA's
consideration with respect to CAA section 112 regulations, and
thereby implicitly permits consideration of any and all measures of
health risk which the Administrator, in [her] judgment, believes are
appropriate to determining what will `protect the public health'.''
See 54 FR at 38057, September 14, 1989. Thus, the level of the MIR
is only one factor to be weighed in determining acceptability of risks.
The Benzene NESHAP explained that ``an MIR of approximately one in 10
thousand should ordinarily be the upper end of the range of
acceptability. As risks increase above this benchmark, they become
presumptively less acceptable under CAA section 112, and would be
weighed with the other health risk
[[Page 95823]]
measures and information in making an overall judgment on
acceptability. Or, the Agency may find, in a particular case, that a
risk that includes MIR less than the presumptively acceptable level is
unacceptable in the light of other health risk factors.'' Id. at 38045.
Similarly, with regard to the ample margin of safety analysis, the EPA
stated in the Benzene NESHAP that: ``EPA believes the relative weight
of the many factors that can be considered in selecting an ample margin
of safety can only be determined for each specific source category.
This occurs mainly because technological and economic factors (along
with the health-related factors) vary from source category to source
category.'' Id. at 38061. We also consider the uncertainties associated
with the various risk analyses, as discussed earlier in this preamble,
in our determinations of acceptability and ample margin of safety.
The EPA notes that it has not considered certain health information
to date in making residual risk determinations. At this time, we do not
attempt to quantify those HAP risks that may be associated with
emissions from other facilities that do not include the source
categories in question, mobile source emissions, natural source
emissions, persistent environmental pollution, or atmospheric
transformation in the vicinity of the sources in these categories.
The Agency understands the potential importance of considering an
individual's total exposure to HAP in addition to considering exposure
to HAP emissions from the source category and facility. We recognize
that such consideration may be particularly important when assessing
non-cancer risks, where pollutant-specific exposure health reference
levels (e.g., RfCs) are based on the assumption that thresholds exist
for adverse health effects. For example, the Agency recognizes that,
although exposures attributable to emissions from a source category or
facility alone may not indicate the potential for increased risk of
adverse non-cancer health effects in a population, the exposures
resulting from emissions from the facility in combination with
emissions from all of the other sources (e.g., other facilities) to
which an individual is exposed may be sufficient to result in increased
risk of adverse non-cancer health effects. In May 2010, the SAB advised
the EPA ``that RTR assessments will be most useful to decision makers
and communities if results are presented in the broader context of
aggregate and cumulative risks, including background concentrations and
contributions from other sources in the area.'' \21\
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\21\ The EPA's responses to this and all other key
recommendations of the SAB's advisory on RTR risk assessment
methodologies (which is available at: http://yosemite.epa.gov/sab/
sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-
007-unsigned.pdf) are outlined in a memorandum to this rulemaking
docket from David Guinnup titled, ``EPA's Actions in Response to the
Key Recommendations of the SAB Review of RTR Risk Assessment
Methodologies.''
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In response to the SAB recommendations, the EPA is incorporating
cumulative risk analyses into its RTR risk assessments, including those
reflected in this proposal. The Agency is: (1) Conducting facility-wide
assessments, which include source category emission points, as well as
other emission points within the facilities; (2) considering sources in
the same category whose emissions result in exposures to the same
individuals; and (3) for some persistent and bioaccumlative pollutants,
analyzing the ingestion route of exposure. In addition, the RTR risk
assessments have always considered aggregate cancer risk from all
carcinogens and aggregate non-cancer HI from all non-carcinogens
affecting the same target organ system.
Although we are interested in placing source category and facility-
wide HAP risks in the context of total HAP risks from all sources
combined in the vicinity of each source, we are concerned about the
uncertainties of doing so. Because of the contribution to total HAP
risk from emission sources other than those that we have studied in
depth during this RTR review, such estimates of total HAP risks would
have significantly greater associated uncertainties than the source
category or facility-wide estimates. Such aggregate or cumulative
assessments would compound those uncertainties, making the assessments
too unreliable.
C. How did we perform the technology review?
Our technology review focused on the identification and evaluation
of developments in practices, processes, and control technologies that
have occurred since the MACT standards were promulgated. Where we
identified such developments, in order to inform our decision of
whether it is ``necessary'' to revise the emissions standards, we
analyzed the technical feasibility of applying these developments and
the estimated costs, energy implications, non-air environmental
impacts, as well as considering the emission reductions. We also
considered the appropriateness of applying controls to new sources
versus retrofitting existing sources.
Based on our analyses of the available data and information, we
identified potential developments in practices, processes, and control
technologies. For this exercise, we considered any of the following to
be a ``development'':
Any add-on control technology or other equipment that was
not identified and considered during development of the original MACT
standards;
Any improvements in add-on control technology or other
equipment (that were identified and considered during development of
the original MACT standards) that could result in additional emissions
reduction;
Any work practice or operational procedure that was not
identified or considered during development of the original MACT
standards;
Any process change or pollution prevention alternative
that could be broadly applied to the industry and that was not
identified or considered during development of the original MACT
standards; and
Any significant changes in the cost (including cost
effectiveness) of applying controls (including controls the EPA
considered during the development of the original MACT standards).
In addition to reviewing the practices, processes, and control
technologies that were considered at the time we originally developed
(or last updated) the NESHAP, we reviewed a variety of data sources in
our investigation of potential practices, processes, or controls to
consider. Among the sources we reviewed were the NESHAP for various
industries that were promulgated since the MACT standards being
reviewed in this action. We reviewed the regulatory requirements and/or
technical analyses associated with these regulatory actions to identify
any practices, processes, and control technologies considered in these
efforts that could be applied to emission sources in the Manufacturing
of Nutritional Yeast source category, as well as the costs, non-air
impacts, and energy implications associated with the use of these
technologies. Additionally, we requested information from facilities
regarding developments in practices, processes, or control technology.
Finally, we reviewed information from other sources, such as state and/
or local permitting agency databases and industry-supported databases.
[[Page 95824]]
IV. Analytical Results and Proposed Decisions
A. What are the results of the risk assessment and analyses?
As described above, for the Manufacturing of Nutritional Yeast
source category, we conducted an inhalation risk assessment for all HAP
emitted. We present results of the risk assessment briefly below and in
more detail in the document: ``Residual Risk Assessment for the
Manufacturing of Nutritional Yeast Source Category in Support of the
December 2016 Risk and Technology Review Proposed Rule,'' which is
available in the docket for this action.
1. Inhalation Risk Assessment Results
Table 2 of this preamble provides a summary of the results of the
inhalation risk assessment for the source category. As discussed in
section III.A.2 of this preamble, we set MACT-allowable HAP emission
levels at nutritional yeast manufacturing facilities equal to actual
emissions. For more detail about the MACT-allowable emission levels,
see the memorandum, ``Emissions Data and Acute Risk Factor Used in
Residual Risk Modeling: Manufacturing of Nutritional Yeast Source
Category,'' which is available in the docket for this action.
Table 2--Nutritional Yeast Manufacturing Inhalation Risk Assessment Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum individual Estimated population Estimated annual Maximum chronic non- Maximum screening
cancer risk (in 1 at increased risk of cancer incidence cancer TOSHI \3\ acute non-cancer HQ
million) \2\ cancer >= 1-in-1 (cases per year) ------------------------ \4\
------------------------ Million ------------------------ -----------------------
Number of facilities \1\ ------------------------ Based on Based on
Based on Based on Based on Based on Based on Based on actual allowable Based on Based on
actual allowable actual allowable actual allowable emissions emissions actual allowable
emissions emissions emissions emissions emissions emissions level \2\ level emissions emissions
level \2\ level level \2\ level level \2\ level level \2\ level
--------------------------------------------------------------------------------------------------------------------------------------------------------
4............................... 2 2 750 750 0.0009 0.0009 0.08 0.08 HQREL = HQREL =
0.2 0.2.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Number of facilities evaluated in the risk analysis.
\2\ Maximum individual excess lifetime cancer risk due to HAP emissions from the source category.
\3\ Maximum TOSHI. The target organ with the highest TOSHI for the Manufacturing of Nutritional Yeast source category is the respiratory system.
\4\ The maximum estimated acute exposure concentration was divided by available short-term threshold values to develop an array of HQ values. HQ values
shown use the lowest available acute threshold value, which in most cases is the REL. When HQ values exceed 1, we also show HQ values using the next
lowest available acute dose-response value. See section III.A.3 of this preamble for explanation of acute dose-response values.
The results of the inhalation risk modeling using actual emissions
data, as shown in Table 2 of this preamble, indicate that the maximum
lifetime individual cancer risk could be up to 2-in-1 million, the
maximum chronic non-cancer TOSHI value could be up to 0.08, and the
maximum off-facility site acute HQ value could be up to 0.2. The total
estimated national cancer incidence from these facilities based on
actual emission levels is 0.0009 excess cancer cases per year or 1 case
in every 1,100 years.
2. Acute Risk Results
Table 2 of this preamble shows the acute risk results for the
Manufacturing of Nutritional Yeast source category. The screening
analysis for acute impacts was based on an industry specific multiplier
of 1.2, to estimate the peak emission rates from the average rates. For
more detailed acute risk results, refer to the draft document:
``Residual Risk Assessment for the Manufacturing of Nutritional Yeast
Source Category in Support of the December 2016 Risk and Technology
Review Proposed Rule,'' which is available in the docket for this
action.
3. Multi-Pathway Risk Screening Results
There are no PB-HAP emitted by facilities in this source category.
Therefore, we do not expect any human health multi-pathway risks as a
result of emissions from this source category.
4. Environmental Risk Screening Results
The emissions data for the Manufacturing of Nutritional Yeast
source category indicate that sources within this source category do
not emit any of the seven pollutants that we identified as
``environmental HAP,'' as discussed earlier in this preamble.
Additionally, the processes and materials used in the source category
typically do not emit any of the seven environmental HAP. Also, we are
unaware of any adverse environmental effect caused by emissions of HAP
that are emitted by this source category (acetaldehyde). Therefore, we
do not expect an adverse environmental effect as a result of HAP
emissions from this source category.
5. Facility-Wide Risk Results
As explained in section III.A.7 of this preamble, we did not
perform a separate facility-wide risk assessment because we expect
facility-wide risks to be equal to the risks we assessed for this
source category.
6. What demographic groups might benefit from this regulation?
To examine the potential for any environmental justice issues that
might be associated with the source category, we performed a
demographic analysis, which is an assessment of risks to individual
demographic groups within the population near the four nutritional
yeast manufacturing facilities that are subject to the NESHAP. In this
analysis, we evaluated the distribution of HAP-related cancer risks and
non-cancer hazards from the nutritional yeast manufacturing facilities
across different social, demographic, and economic groups within the
populations living near facilities identified as having the highest
risks. The methodology and the results of the demographic analyses are
included in a technical report, ``Risk and Technology Review--Analysis
of Socio-Economic Factors for Populations Living Near Nutritional Yeast
Manufacturing Facilities,'' available in the docket for this action.
The analysis indicates that the minority population living within
50 km (1,700,000 people, of whom 41 percent are minority) and within 5
km (131,567 people, of whom 68 percent are minority) of the four
nutritional yeast manufacturing facilities is greater than the minority
population found nationwide (28 percent). The specific
[[Page 95825]]
demographics of the population within 5 and 50 km of the facilities
indicate potential disparities in risks in certain demographic groups,
including the ``African American,'' ``Below the Poverty Level,'' and
``Over 25 and without high school diploma'' groups.
When examining the risk levels of those exposed to emissions from
the four nutritional yeast manufacturing facilities, we find
approximately 750 persons are exposed to a cancer risk greater than or
equal to 1-in-1 million, and the highest cancer risk for these
individuals is less than 2-in-1 million. Of these 750 persons, 100
percent of them are defined as minority. When examining the noncancer
risks surrounding these facilities, no one is predicted to have a
chronic non-cancer TOSHI greater than 1.
B. What are our proposed decisions regarding risk acceptability, ample
margin of safety, and adverse environmental effects?
1. Risk Acceptability
As noted in section III.B of this preamble, we weigh all health
risk factors in our risk acceptability determination, including the
cancer MIR, the number of persons in various cancer and non-cancer risk
ranges, cancer incidence, the maximum non-cancer TOSHI, the maximum
acute non-cancer HQ, the extent of non-cancer risks, the potential for
adverse environmental effects, the distribution of cancer and non-
cancer risks in the exposed population, and risk estimation
uncertainties (54 FR 38044, September 14, 1989).
For the Manufacturing of Nutritional Yeast source category, the
risk analysis indicates that the cancer risks to the individual most
exposed could be up to 2-in-1 million due to actual emissions and up to
2-in-1 million based on allowable emissions. As explained in section
III.A.2 of this preamble, we determined that actual emissions provide
an accurate representation of maximum emissions from the source
category and used the actual emissions in both steps of the risk
assessment (i.e., determination of risk based on actual and MACT-
allowable emissions). These risks are considerably less than 100-in-1
million, which is the presumptive upper limit of acceptable risk. The
risk analysis also shows very low cancer incidence (0.0009 cases per
year), as well as no potential for adverse chronic or multi-pathway
health effects. In addition, the risk assessment indicates no
significant potential for multi-pathway health effects or adverse
environmental effects. The acute non-cancer risks based on actual and
allowable emissions are all below an HQ of 1. Therefore, we find there
is little potential concern of acute non-cancer health impacts from
actual and allowable emissions.
Considering all of the health risk information and factors
discussed above, including the uncertainties discussed in section
III.A.8 of this preamble, we propose to find that the risks from the
Manufacturing of Nutritional Yeast source category are acceptable.
2. Ample Margin of Safety Analysis
Although we are proposing that the risks from the Manufacturing of
Nutritional Yeast source category are acceptable, risk estimates for
approximately 750 individuals in the exposed population are above 1-in-
1 million at the actual and MACT-allowable emissions levels.
Consequently, we further considered whether the MACT standards for the
Manufacturing of Nutritional Yeast source category provide an ample
margin of safety to protect public health. In this ample margin of
safety analysis, we investigated available emissions control options
that might reduce the risk from the source category. We considered this
information along with all of the health risks and other health
information considered in our determination of risk acceptability.
As discussed in section IV.C of this preamble, during the
technology review for this source category, we evaluated two control
technologies for reducing acetaldehyde emissions from fermenters at
nutritional yeast facilities: Thermal oxidizers and wet (packed bed)
scrubbers. Thermal oxidizers have the potential to reduce total
acetaldehyde emissions from this source category by 11 tpy to 36 tpy,
for a total of 90 tpy for the industry, but would also lead to
increases in energy use and emissions of approximately 89 tpy of
nitrogen oxides (NOX) from these facilities. The cost
effectiveness for thermal oxidizers varied per facility, with an
average cost of $56,000 per ton of acetaldehyde reduced. The average
cost effectiveness for packed bed scrubbers was $74,000 per ton of
acetaldehyde per facility. The use of packed bed scrubbers would also
lead to additional environmental impacts, such as increased energy and
water usage, as well as the need to use and dispose of solvents. These
cost-effectiveness values are significantly higher than values that we
have historically deemed to be cost effective for organic HAP in other
NESHAP. Due to the additional environmental impacts that would be
imposed and the low level of current risk, along with the substantial
costs associated with these options, we are proposing that additional
emissions controls for this source category are not necessary to
provide an ample margin of safety.
3. Environmental Effects
We did not identify emissions of any of the seven environmental HAP
included in our environmental risk screening, and are unaware of any
adverse environmental effects caused by HAP emitted by this source
category (acetaldehyde). Therefore, we do not expect there to be an
adverse environmental effect as a result of HAP emissions from this
source category and we are proposing that it is not necessary to set a
more stringent standard to prevent, taking into consideration costs,
energy, safety, and other relevant factors, an adverse environmental
effect.
C. What are the results and proposed decisions based on our technology
review?
In order to fulfill our obligations under CAA section 112(d)(6), we
conducted a technology review to identify developments in practices,
processes, and control technologies that may advise revisions to the
current NESHAP standards applicable to the Manufacturing of Nutritional
Yeast source category (i.e., 40 CFR part 63, subpart CCCC). In
conducting our technology review, we utilized the RBLC database,
reviewed title V permits for each nutritional yeast facility, and
reviewed regulatory actions related to emissions controls at similar
sources that could be applicable to nutritional yeast manufacturing
facilities.
After reviewing information from the sources above, we identified
two control technologies for further evaluation that are technically
feasible for use at nutritional yeast facilities: thermal oxidizers and
wet scrubbers.\22\ These control technologies were identified both in
the RBLC database and in a review of the miscellaneous organic chemical
manufacturing NESHAP (MON). The RBLC database contains multiple sources
with similar production processes as nutritional yeast manufacturing
facilities that employ thermal oxidizers or wet scrubbers, e.g.,
fermenters at ethanol facilities. We also identified the MON in
particular as being a potentially useful analog for manufacturing of
nutritional yeast because the MON regulates
[[Page 95826]]
emissions from ethanol fermenters (the same sources identified in the
RBLC) that are located at facilities that are major sources of HAP
emissions. Our review of this rule revealed that facilities use thermal
oxidizers as a control technology to comply with the process vent
emission limits in the MON.
---------------------------------------------------------------------------
\22\ Additional information about this determination is
documented in the memorandum, ``Technology Review for the
Manufacturing of Nutritional Yeast Source Category,'' which is
available in the docket for this action.
---------------------------------------------------------------------------
After identifying control technologies that are technically
feasible for reducing acetaldehyde emissions from nutritional yeast
fermenters, we then evaluated the costs and emissions reductions
associated with installing regenerative thermal oxidizers (RTOs) and
packed bed scrubbers at each of the four nutritional yeast facilities.
The total capital investment to install RTOs ranged from $2 million to
$6.9 million per facility for a total of approximately $14.9 million
for the industry. Annual costs for each facility were approximately
$0.8 million to $2.2 million, for a total of $5.2 million per year for
the industry. Applying a control efficiency of 98 percent, acetaldehyde
emissions for each facility would be reduced by approximately 11 tpy to
36 tpy, for a total of 90 tpy for the industry. To install RTOs at each
facility, the resulting cost effectiveness ranged from $32,000 to
$90,000 per ton of acetaldehyde reduced. Furthermore, use of RTOs would
result in increased energy use and NOX emissions of
approximately 89 tpy from nutritional yeast manufacturing facilities.
Additional information about the assumptions and methodologies used in
these calculations is documented in the memorandum, ``Technology Review
for the Manufacturing of Nutritional Yeast Source Category,'' which is
available in the docket for this action.
The total capital investment to install packed bed scrubbers on
fermenters ranged from $3 million to $11.6 million per facility for a
total of about $24.5 million for the industry. Annual costs for each
facility were approximately $0.8 million to $2.5 million, for a total
of $5.8 million per year for the industry. Applying a control
efficiency of 85 percent, acetaldehyde emissions for each facility
would be reduced by approximately 9.4 tpy to 31 tpy, for a total of 78
tpy for the industry. To install packed bed scrubbers at each facility,
the resulting cost effectiveness ranged from $43,000 to $110,000 per
ton of acetaldehyde reduced. Furthermore, the use of packed bed
scrubbers would lead to increased energy usage and other environmental
impacts, such as the usage and disposal of water and caustic solutions
(e.g., sodium hydroxide). These cost-effectiveness values are
significantly higher than values that we have historically deemed to be
cost effective for organic HAP in other NESHAP. Additional information
about the assumptions and methodologies used in these calculation is
documented in the memorandum, ``Technology Review for the Manufacturing
of Nutritional Yeast Source Category,'' which is available in the
docket for this action.
Considering the high costs per ton of acetaldehyde reduced and
potential adverse environmental impacts associated with the
installation of RTOs or packed bed scrubbers, we did not consider these
technologies to be cost effective for further reducing acetaldehyde
emissions from fermenters at nutritional yeast manufacturing
facilities. In light of the results of the technology review, we
conclude that changes to the fermenter emission limits are not
warranted pursuant to CAA section 112(d)(6). We solicit comment on our
proposed decision.
D. What other actions are we proposing?
We are proposing revisions to the malfunction provisions of the
MACT rule in order to ensure that they are consistent with the Court
decision in Sierra Club v. EPA, 551 F. 3d 1019 (D.C. Cir. 2008), which
vacated two provisions that exempted sources from the requirement to
comply with otherwise applicable CAA section 112(d) emission standards
during periods of startup, shutdown, and malfunction (SSM). We are
proposing revisions to the form of the VOC emission limits for
fermenters to address this issue. We also are proposing various other
changes to testing, monitoring, recordkeeping, and reporting
requirements. Our analyses and proposed changes related to these issues
are presented below.
1. Fermenter VOC Emission Limits
The Manufacturing of Nutritional Yeast NESHAP currently requires
that 98 percent of all batches meet the fermenter batch average VOC
emission limits, on a 12-month rolling basis. However, this requirement
allows 2 percent of the batches to exceed the standard. This
formulation of the standard is in direct conflict with the statutory
requirement that emission standards apply at all times, as discussed in
Sierra Club v. EPA. 551 F. 3d 1019 (D.C. Cir. 2008). As a result, the
EPA reviewed the current fermenter VOC emission limits and is proposing
revisions to the form of the standard. We are proposing to revise the
form of the standard in Table 1 to 40 CFR part 63, subpart CCCC such
that each batch must meet the existing VOC concentration limits (300
ppmv for stock fermentation, 200 ppmv for first generation
fermentation, and 100 ppmv for trade fermentation), which is referred
to as the ``Batch Option'' in the proposed revisions.
In recognition that the yeast manufacturing process is biological
and does not produce the exact same level of emissions from every
batch, the proposed amendments also include an alternative compliance
method in Table 1 to 40 CFR part 63, subpart CCCC that allows
facilities to average the VOC concentration data from all batches
within each fermentation stage over a rolling 12-month period. When
manufacturing yeast, increased acetaldehyde levels indicate
inefficiencies in the manufacturing process; consequently, facilities
have a financial incentive to reduce emissions as much as possible
through process controls. However, to ensure that the averaging method
will be at least as stringent as the emission standards without
averaging, we are proposing a 5-percent discount factor in the VOC
emission limit for each stage, i.e., 285 ppmv for stock fermentation,
190 ppmv for first generation fermentation, and 95 ppmv for trade
fermentation. For example, if this alternative option is selected, all
batch average VOC concentration data for the trade fermentation stage
in a 12-month period must be averaged together and this average must
not exceed 95 ppmv VOC instead of the limit of 100 ppmv VOC for
individual batches. This option is referred to as the ``Average
Option'' in the proposed revisions to 40 CFR part 63, subpart CCCC.
This alternative provides sources with flexibility on ways to comply
with the standard, while maintaining the sources' accountability for
meeting health and environmental goals and maintaining the
enforceability of the emission limits by regulatory authorities. We
expect that allowing facilities to average emissions over the period of
1 year will provide flexibility for changes in production over time
without allowing for wide-ranging fluctuations in HAP emissions. The
use of a rolling annual calculation period with semiannual compliance
reports, including monthly updates of the annual average emission
calculations, protects against emission peaks so health and welfare
effects are avoided. This proposed alternative method of demonstrating
compliance also minimizes the recordkeeping and reporting impacts of
the changes for facilities and regulatory authorities, since the
current rule requires the same compliance periods. The EPA requests
[[Page 95827]]
comment on the proposed revisions to the form of the fermenter VOC
emission limits. Additionally, we request comment on whether it is
appropriate to use a discount factor and what value between 0 and 10
percent should be selected for the discount factor.
We are also proposing changes to 40 CFR 63.2171 and Table 4 to 40
CFR part 63, subpart CCCC that specify the procedures facilities must
use to demonstrate continuous compliance with either of the two
proposed forms of the emission limits in Table 1 to 40 CFR part 63,
subpart CCCC. The proposed changes require facilities to immediately
begin demonstrating continuous compliance with one of the two proposed
forms of the emission limits (i.e., the Average Option or the Batch
Option) upon the effective date of the final rule.
For the proposed Average Option, the changes to 40 CFR 63.2171 and
Table 4 to 40 CFR part 63, subpart CCCC require facilities to calculate
compliance on a monthly basis using data from every batch produced
during the previous 12 months. The proposed amendments to 40 CFR
63.2150 remove the exemption that allows facilities to exceed emissions
during periods of malfunction. The proposed amendments to 40 CFR
63.2170 retain the provision that data recorded during monitoring
malfunctions, associated repairs, and required quality assurance or
quality control activities must not be used to report emissions.
Therefore, data from batches that were produced during periods of
malfunctions over the past 12 months, other than those related to the
monitoring system, must now be included in the calculations used to
determine compliance. Additionally, instead of calculating a single
determination of compliance based on the emissions from all batches
regardless of fermentation stage, facilities must now determine
compliance for batches within each of the three fermentation stages
that have specific emission limits in Table 1 to 40 CFR part 63,
subpart CCCC. Based on information collected during the site visits,
the EPA expects that facilities have the necessary data available to
make these changes to the methods used to determine compliance upon
promulgation of the final rule.
For the proposed Batch Option, the changes to 40 CFR 63.2171 and
Table 4 to 40 CFR part 63, subpart CCCC require facilities to
demonstrate that the average VOC concentration for each individual
batch produced during a semiannual compliance period did not exceed the
applicable emission limits. As noted above, this now includes data from
batches that were produced during periods of malfunctions, other than
malfunctions related to the monitoring system. Based on information
collected during the site visits, the EPA expects that facilities have
the necessary data available to make these changes to the methods used
to determine compliance upon promulgation of the final rule.
The EPA requests comment on the proposed timeframe to demonstrate
compliance using the revised form of the emission limits upon
promulgation of the final rule and the availability of data necessary
to comply within this timeframe.
2. Testing, Monitoring, Recordkeeping, and Reporting Requirements
We propose to revise the rule's testing, monitoring, recordkeeping,
and reporting requirements in five ways: (1) Owners or operators must
demonstrate compliance by using a VOC continuous emission monitoring
system (CEMS) to determine the VOC concentration in the fermenter
exhaust (i.e., we are removing the option to monitor brew ethanol and
calculate VOC concentration using a correlation); (2) owners or
operators may not use a gas chromatographic (GC) CEMS to monitor VOC
concentration; (3) owners or operators must have valid CEMS data from
each hour of the entire batch monitoring period and report periods of
missing data as deviations; (4) owners or operators of VOC CEMS must
conduct annual performance tests (relative accuracy test audits
(RATAs)) using Procedure 1 of appendix F to part 60 to evaluate the
performance of the installed VOC CEMS over an extended period of time;
and (5) owners or operators must provide compliance reports
electronically.
a. Proposed Removal of the Option to Monitor Brew Ethanol
Subpart CCCC of 40 CFR part 63 currently allows owners or operators
to monitor brew ethanol in the fermenter liquid and determine an annual
correlation to VOC concentration in the fermenter exhaust in order to
demonstrate compliance with fermenter VOC emission limits. We are
proposing to revise the requirements of 40 CFR 63.2166 and 63.2171 and
Table 3 and Table 4 to 40 CFR part 63, subpart CCCC to remove the
option to monitor brew ethanol.
Currently, one facility demonstrates compliance by monitoring brew
ethanol and submits annual reports showing the results of performance
testing and development of the correlation equation for each
fermentation stage.\23\ We reviewed reports for the past 5 years (2012-
2016) and found that individual equations showed strong correlations
with the data obtained during the applicable performance tests.
However, the reports also showed a high level of variability between
the equations for each fermentation stage across the 5-year period. A
fermentation stage characterized by a correlation equation with a
higher slope results in higher VOC emissions estimates per percent
ethanol measured in the brew, while a correlation equation with a lower
slope results in lower VOC emissions estimates per percent ethanol in
the brew. Therefore, applying equations with different slopes to the
same brew ethanol concentration yields different estimates of VOC
emissions. A review of reports from the previous 5 years shows a high
level of inconsistency in the amount of VOC emissions estimated for a
particular brew ethanol percentage each year. The practical effect of
these variations is that estimates of VOC concentrations from a given
fermentation stage can almost double for a single brew ethanol
concentration, depending on the correlation equation used. This has the
greatest effect on concentrations at the higher end of the normal range
for each stage of fermentation. To illustrate the effect, we selected a
brew ethanol concentration at the higher end of the range of brew
ethanol concentration data for each of the fermentation stages and
determined the corresponding range of VOC concentrations, based on the
most recent 5 years of correlation data. The results showed that for
each fermentation stage, a given brew ethanol concentration would meet
the compliance emission limit in some years, but greatly exceed it in
other years; see Table 3 of this preamble. The 5 years of correlation
data are presented in the memorandum, ``Brew Ethanol Correlation Review
for the Manufacturing of Nutritional Yeast Source Category,'' which is
available in the docket for this action.
---------------------------------------------------------------------------
\23\ The correlation equation is used to estimate the
concentration of VOC in the fermenter exhaust for a given percentage
of ethanol (measured in the fermenter brew).
[[Page 95828]]
Table 3--Range of VOC Concentration for Each Fermentation Stage, Based on Brew Ethanol Correlation Data
----------------------------------------------------------------------------------------------------------------
VOC emission
Brew ethanol VOC concentration range, ppmv as limitation,
Fermentation stage concentration, propane ppmv as
% propane\1\
----------------------------------------------------------------------------------------------------------------
Third-to-last................................ 0.25 188 to 372....................... 300
Second-to-last............................... 0.20 109 to 227....................... 200
Last......................................... 0.125 73 to 170........................ 100
----------------------------------------------------------------------------------------------------------------
\1\ As specified in Table 1 to 40 CFR part 63, subpart CCCC.
As mentioned above, individual equations typically exhibited strong
statistical correlations for the data used to develop them, which
indicates that there is a relationship between VOC emissions and brew
ethanol concentration for a given batch. However, the observed
variability between equations indicates the correlation between VOC
emissions and brew ethanol concentration is different for each batch.
This means that the correlation developed for one batch may not be
representative of the correlation between VOC emissions and brew
ethanol concentration for any other batch. Given that estimates of VOC
concentrations from a given fermentation stage can almost double for a
single brew ethanol concentration, depending on the correlation
equation used, a batch that appears to be in compliance could, in fact,
be out of compliance.
The manufacturing of yeast is a biological process and some degree
of variation is expected. However, emissions are also determined by a
few key process parameters, including the amount of available oxygen
and the composition and amount of the sugar and nutrient mixture fed to
the yeast in each batch. As noted on the site visits, the amount of
oxygen does not vary significantly between batches. Fermenters are
equipped with aeration systems, which operate at full capacity for
every batch. In contrast, the composition of the sugar source can vary
greatly from one batch to the next. Market factors (e.g., price,
availability, competition) drive the purchase of sugar sources, such as
molasses, throughout the year. Purchases are made frequently and there
is some on-site storage, allowing operators of nutritional yeast
manufacturing facilities to blend different materials together at
times. While the composition of the mixture is optimized for yeast
growth given the materials on hand at any given time, the specific
composition fluctuates throughout the year. It is likely that the
differences in composition of the sugar source for each batch explains
much of the variance observed in the correlation equations analyzed
above.
In order to establish a reliable correlation between VOC emissions
and brew ethanol for each batch, a new performance test would need to
be conducted every time the sugar source changes. At facilities where
the sugar source changes frequently, this requirement would pose a
significant financial and logistic burden with results that were of
limited applicability. In addition, it would create significant
challenges for the regulatory authority responsible for enforcing the
frequency and validity of the performance tests.
Reliable emissions data are critical to ensuring compliance with
the established emission limits, which is necessary to reduce the
emissions of HAP and protect public health and the environment.
Therefore, the EPA is proposing to remove the option to demonstrate
compliance with the emission limits by monitoring brew ethanol, and to
require all facilities to monitor fermenter exhaust using CEMS.
We are proposing to allow facilities to continue to monitor brew
ethanol for up to 1 year after the promulgation of any such proposed
rule revisions. This transition period would help ensure continuous
compliance with the emission limits while allowing time to install CEMS
(see proposed 40 CFR 63.2171). Additionally, because no new facilities
are currently under construction, we are proposing to remove
requirements in 40 CFR 63.2160, 63.2166, 63.2180, and Table 3 to 40 CFR
part 63, subpart CCCC related to the demonstration of initial
compliance by monitoring brew ethanol. New affected sources would not
be able to demonstrate initial compliance by monitoring brew ethanol.
We are proposing to revise language in 40 CFR 63.2164 to reference
a ``brew ethanol monitor'' and not a ``CEMS'' to monitor brew ethanol.
CEMS is not the correct term to describe the monitoring device for brew
ethanol. The term ``brew ethanol monitor'' is already defined in the
current rule, and the proposed revisions correctly incorporate its use
into the rule language.
The EPA specifically requests comments on whether the option to
demonstrate compliance by monitoring brew ethanol and developing a
correlation to VOC concentration in the fermenter exhaust should be
retained if performance tests to determine the correlation are
conducted more frequently. Commenters should address the frequency of
the correlation recalculation (using performance testing) needed to
provide reliable emissions data that will consistently reflect accurate
emissions for each batch and explain the basis for their conclusions.
b. Proposed Removal of GC CEMS
The current rule allows the use of CEMS that generate a single
combined response value for VOC (VOC CEMS) or that rely upon GC CEMS,
if they are constructed and operated according to the applicable
Performance Specification (PS) of 40 CFR part 60, appendix B, to
monitor VOC emissions (40 CFR 63.2163). However, nutritional yeast
manufacturing facilities emit a mixture of VOCs and the emission limits
for these facilities are stated for total VOC (as opposed to specific
VOC species). While VOC CEMS constructed and operated according to PS 8
can measure total VOCs, GC CEMS constructed and operated according to
PS 9 are suitable for measuring a few specific VOC species. Based on
information collected during the site visits, we are not aware of any
facilities currently using GC CEMS. Therefore, we propose to revise 40
CFR 63.2163 to remove the option to use GC CEMS to monitor VOC
concentration. The EPA requests comment on this proposed revision.
c. Proposed Collection of All Valid CEMS Data From the Entire Batch
Monitoring Period.
The current rule requires owners or operators who monitor fermenter
exhaust to have valid CEMS data from at least 75 percent of the full
hours over
[[Page 95829]]
the entire batch, and that a valid hour of data must have one data
point for each 30-minute period. In the 15 years since the rule was
promulgated, there have been continued improvements in CEMS reliability
as well as a change in the data collection approach. In many NESHAP,
CEMS are required to collect, process, and report results of the
sampling at least once every 15 minutes. Some CEMS are able to complete
the process cycle more often than every 15 minutes. Moreover, many
regulatory authorities no longer have minimum valid data requirements
for emissions data. Rather, each source owner or operator is expected
to collect as much data as possible and to report periods of missing
data, along with the reason for such periods, to the regulatory
authority who determines what, if any, follow-up action would be
required.\24\ Such an approach is included in our recently promulgated
Mercury Air Toxics Standard (MATS). MATS requires owners or operators
to collect data at all times the electric generation unit (EGU)
operates; failure to collect the required data is a deviation from
monitoring requirements. EGU owners or operators are to describe,
explain, and report deviations in ongoing compliance reports and to
keep records of deviations.\25\
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\24\ See Indiana's Compliance Branch CEMS Guidance Manual,
section 4.5 on page 19 of chapter 2, available at http://www.in.gov/idem/files/aircom_cems_chapter_2.pdf.
\25\ See 40 CFR 63.10020(b), 10020(d), 10021(g), 10031(c)(9),
and 10032(a)(4).
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We propose to revise 40 CFR 63.2163, 63.2170, 63.2181(c)(7), and
63.2182(b)(9) to require owners or operators of nutritional yeast
sources to follow this model. Owners or operators would be required to
collect VOC concentration data at all times of batch operation. Failure
to collect VOC concentration data would be a deviation of monitoring
requirements and would trigger generation of a report identifying the
periods during which data were not collected, a description of the
deviation event, and an explanation as to why the deviation occurred.
The owner or operator would also be required to maintain records of
each deviation. In addition, owners or operators would report the hours
of deviation, along with the hours of batch operation. Relying on
reported information, regulatory authorities would determine what, if
any, follow-up correction or enforcement action should occur. The EPA
requests comment on this proposed revision and its incorporation into
the rule.
d. Proposed Use of Procedure 1 of Appendix F to Part 60 for VOC CEMS
The current rule requires owners or operators of nutritional yeast
manufacturing facilities to monitor compliance using either VOC or GC
CEMS. Additionally, the rule exempts owners or operators that use a VOC
CEMS with a flame ionization analyzer from conducting the RATAs
required by PS 8. As discussed in section IV.D.2.b of this preamble, we
are proposing to remove the option to monitor compliance using a GC
CEMS and the related installation requirements. The current rule
requires owners or operators to install and certify VOC CEMS according
to PS 8. Use of PS 8 ensures that the VOC CEMS has been installed
properly, but it lacks ongoing quality assurance and quality control
(QA/QC) procedures to ensure that a properly installed VOC CEMS
continues to operate appropriately. Such procedures are included in
Procedure 1 of appendix F to part 60. In order to clarify the minimum
requirements for owners or operators to ensure their VOC CEMS continue
to produce valid data, we propose to revise 40 CFR 63.2163 to include
the requirements of Procedure 1 of appendix F to part 60, where propane
would be used for the calibration gas and Method 25A would be used as
the Reference Method (RM). In doing so, we are also removing the
exemption for owners and operators of nutritional yeast manufacturing
facilities that monitor VOC emissions using a flame ionization analyzer
from conducting the relative-accuracy test PS 8 requires. Incorporation
of a consistent set of ongoing QA/QC requirements will not only provide
assurance that the ongoing collected data are valid, but also ensure a
consistent basis for collecting those data.
Moreover, we propose to replace the outdated reference 2 of PS 8,
``A Procedure for Establishing Traceability of Gas Mixtures to Certain
National Bureau of Standards Standard Reference Materials,'' with the
current version of our traceability protocol. In the revised regulatory
text of 40 CFR part 63, subpart CCCC, the EPA is proposing to
incorporate by reference EPA/600/R-12/531, EPA Traceability Protocol
for Assay and Certification of Gaseous Calibration Standards, May 2012,
at 40 CFR 63.2163(b)(2), in accordance with requirements of 1 CFR 51.5.
The protocol is used to certify calibration gases for continuous
emission monitors and specifies methods for assaying gases and
establishing traceability to National Institute of Standards and
Technology reference standards.\26\ The EPA has made, and will continue
to make, documents that are incorporated by reference generally
available electronically through http://www.regulations.gov and/or in
hard copy at the appropriate EPA office (see the ADDRESSES section of
this preamble for more information). The EPA requests comment on the
proposed QA/QC procedures and CEMS RATA revisions.
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\26\ Additional information about the traceability protocol is
available at https://www.epa.gov/air-research/epa-traceability-protocol-assay-and-certification-gaseous-calibration-standards.
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e. Electronic Reporting
Through this action, the EPA is proposing to amend 40 CFR
63.2181(a) to require that owners or operators of nutritional yeast
manufacturing facilities submit electronic copies of compliance
reports, which include performance test and performance evaluation
results, through the EPA's Central Data Exchange (CDX) using the
Compliance and Emissions Data Reporting Interface (CEDRI). The EPA
believes that the electronic submittal of the reports addressed in this
proposed rulemaking will increase the usefulness of the data contained
in those reports, is in keeping with current trends in data
availability, will further assist in the protection of public health
and the environment, and will ultimately result in less burden on the
regulated community. Under current requirements, paper reports are
often stored in filing cabinets or boxes, which make the reports more
difficult to obtain and use for data analysis and sharing. Electronic
storage of such reports would make data more accessible for review,
analyses, and sharing. Electronic reporting can also eliminate paper-
based, manual processes, thereby saving time and resources, simplifying
data entry, eliminating redundancies, minimizing data reporting errors,
and providing data quickly and accurately to the affected facilities,
air agencies, the EPA, and the public.
In 2011, in response to Executive Order 13563, the EPA developed a
plan \27\ to periodically review its regulations to determine if they
should be modified, streamlined, expanded, or repealed in an effort to
make regulations more effective and less burdensome. The plan includes
replacing outdated paper reporting with electronic reporting. In
keeping with this plan and the White House's Digital Government
[[Page 95830]]
Strategy,\28\ in 2013 the EPA issued an agency-wide policy specifying
that new regulations will require reports to be electronic to the
maximum extent possible. By requiring electronic submission of
specified reports in this proposed rule, the EPA is taking steps to
implement this policy.
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\27\ EPA's Final Plan for Periodic Retrospective Reviews, August
2011. Available at: https://www.epa.gov/sites/production/files/2015-09/documents/eparetroreviewplan-aug2011_0.pdf.
\28\ Digital Government: Building a 21st Century Platform to
Better Serve the American People, May 2012. Available at: https://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government-strategy.pdf.
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The EPA Web site that stores the submitted electronic data,
WebFIRE, will be easily accessible to everyone and will provide a user-
friendly interface that any stakeholder could access. By making data
readily available, electronic reporting increases the amount of data
that can be used for many purposes. One example is the development of
emissions factors. An emissions factor is a representative value that
attempts to relate the quantity of a pollutant released to the
atmosphere with an activity associated with the release of that
pollutant (e.g., kilograms of particulate emitted per megagram of coal
burned). Such factors facilitate the estimation of emissions from
various sources of air pollution and are an important tool in
developing emissions inventories, which in turn are the basis for
numerous efforts, including trends analysis, regional and local scale
air quality modeling, regulatory impact assessments, and human exposure
modeling. Emissions factors are also widely used in regulatory
applicability determinations and in permitting decisions.
The EPA has received feedback from stakeholders asserting that many
of the EPA's emissions factors are outdated or not representative of a
particular industry emission source. While the EPA believes that the
emissions factors are suitable for their intended purpose, we recognize
that the quality of emissions factors varies based on the extent and
quality of underlying data. We also recognize that emissions profiles
on different pieces of equipment can change over time due to a number
of factors (fuel changes, equipment improvements, industry work
practices), and it is important for emissions factors to be updated to
keep up with these changes. The EPA is currently pursuing emissions
factor development improvements that include procedures to incorporate
the source test data that we are proposing be submitted electronically.
By requiring the electronic submission of the reports identified in
this proposed action, the EPA would be able to access and use the
submitted data to update emissions factors more quickly and
efficiently, creating factors that are characteristic of what is
currently representative of the relevant industry sector. Likewise, an
increase in the number of test reports used to develop the emissions
factors will provide more confidence that the factor is of higher
quality and representative of the whole industry sector.
Additionally, by making the records, data, and reports addressed in
this proposed rulemaking readily available, the EPA, the regulated
community, and the public will benefit when the EPA conducts its CAA-
required technology and risk-based reviews. As a result of having
performance test reports and air emission reports readily accessible,
our ability to carry out comprehensive reviews will be increased and
achieved within a shorter period of time. These data will provide
useful information on control efficiencies being achieved and
maintained in practice within a source category and across source
categories for regulated sources and pollutants. These reports can also
be used to inform the technology-review process by providing
information on improvements to add-on control technology and new
control technology.
Under an electronic reporting system, the EPA's Office of Air
Quality Planning and Standards (OAQPS) would have air emissions and
performance test data in hand; OAQPS would not have to collect these
data from the EPA Regional offices or from delegated air agencies or
industry sources in cases where these reports are not submitted to the
EPA Regional offices. Thus, we anticipate fewer or less substantial
information collection requests (ICRs) in conjunction with prospective
CAA-required technology and risk-based reviews may be needed. We expect
this to result in a decrease in time spent by industry to respond to
data collection requests. We also expect the ICRs to contain less
extensive stack testing provisions, as we will already have stack test
data electronically. Reduced testing requirements would be a cost
savings to industry. The EPA should also be able to conduct these
required reviews more quickly, as OAQPS will not have to include the
ICR collection time in the process or spend time collecting reports
from the EPA Regional Offices. While the regulated community may
benefit from a reduced burden of ICRs, the general public benefits from
the Agency's ability to provide these required reviews more quickly,
resulting in increased public health and environmental protection.
Electronic reporting could minimize submission of unnecessary or
duplicative reports in cases where facilities report to multiple
government agencies and the agencies opt to rely on the EPA's
electronic reporting system to view report submissions. Where air
agencies continue to require a paper copy of these reports and will
accept a hard copy of the electronic report, facilities will have the
option to print paper copies of the electronic reporting forms to
submit to the air agencies, and, thus, minimize the time spent
reporting to multiple agencies. Additionally, maintenance and storage
costs associated with retaining paper records could likewise be
minimized by replacing those records with electronic records of
electronically submitted data and reports.
Air agencies could benefit from more streamlined and automated
review of the electronically submitted data. For example, because the
performance test data would be readily-available in a standard
electronic format, air agencies would be able to review reports and
data electronically rather than having to conduct a review of the
reports and data manually. Having reports and associated data in
electronic format will facilitate review through the use of software
``search'' options, as well as the downloading and analyzing of data in
spreadsheet format. Additionally, air agencies would benefit from the
reported data being accessible to them through the EPA's electronic
reporting system wherever and whenever they want or need access (as
long as they have access to the Internet). The ability to access and
review air emission report information electronically will assist air
agencies to more quickly and accurately determine compliance with the
applicable regulations, potentially allowing a faster response to
violations which could minimize harmful air emissions. This benefits
both air agencies and the general public.
The proposed electronic reporting of data is consistent with
electronic data trends (e.g., electronic banking and income tax
filing). Electronic reporting of environmental data is already common
practice in many media offices at the EPA. The changes being proposed
in this rulemaking are needed to continue the EPA's transition to
electronic reporting.
3. Startup, Shutdown, and Malfunction Requirements
In 2008, the United States Court of Appeals for the District of
Columbia Circuit vacated portions of two provisions in the EPA's CAA
section 112 regulations governing the emissions of HAP during periods
of SSM. Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir.
[[Page 95831]]
2008). Specifically, the Court vacated the SSM exemption contained in
40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), holding that under section
302(k) of the CAA, emissions standards or limitations must be
continuous in nature and that the SSM exemption violates the CAA's
requirement that some section 112 standards apply continuously.
While the current rule does not exempt periods of startup and
shutdown from emissions standards, we are proposing several changes to
eliminate the malfunction exemption that is contained in this rule.
While, for simplicity, we refer throughout this section to the SSM
exemption and the associated SSM plan requirements, only the
malfunction exemption and its removal are relevant to this action
because periods of startup and shutdown were never exempt from
emissions standards in this subpart. As discussed earlier in this
preamble (section IV.D.1), we are proposing standards in this rule that
apply at all times (i.e., to all batches), consistent with Sierra Club
v. EPA. We are also proposing revisions to several provisions of 40 CFR
part 63, subpart CCCC and to Table 6 to 40 CFR part 63, subpart CCCC
(the General Provisions Applicability Table) as is explained in more
detail below. For example, we are proposing to eliminate the
incorporation of the General Provisions' requirement that the source
develop an SSM plan. We also are proposing to eliminate and revise
certain recordkeeping and reporting requirements related to the SSM
exemption as further described below.
The EPA has attempted to ensure that the provisions we are
proposing to eliminate are inappropriate, unnecessary, or redundant in
the absence of the SSM exemption. We are specifically seeking comment
on whether we have successfully identified all such provisions and
whether any of the identified provisions retain utility even in the
absence of the SSM exemption.
In proposing the standards in this rule, the EPA has taken into
account startup and shutdown periods and, for the reasons explained
below, has not proposed alternate standards for those periods.
Periods of startup, normal operations, and shutdown are all
predictable and routine aspects of a source's operations. In this
NESHAP, owners and operators of nutritional yeast manufacturing
facilities employ process controls to limit emissions. These process
controls are employed from the time a fermenter starts production of a
batch of yeast and continue until the fermenter is emptied of yeast.
Additionally, emissions are averaged over the entire duration of each
batch in order to meet emission limits, so there was no need to set
separate limits for periods of startup and shutdown in this rule.
Malfunctions, in contrast, are neither predictable nor routine.
Instead they are, by definition, sudden, infrequent, and not reasonably
preventable failures of emissions control, process, or monitoring
equipment. 40 CFR 63.2 (definition of malfunction). The EPA interprets
CAA section 112 as not requiring emissions that occur during periods of
malfunction to be factored into development of CAA section 112
standards. Under CAA section 112, emissions standards for new sources
must be no less stringent than the level ``achieved'' by the best
controlled similar source and for existing sources generally must be no
less stringent than the average emission limitation ``achieved'' by the
best performing 12 percent of sources in the category. There is nothing
in CAA section 112 that directs the Agency to consider malfunctions in
determining the level ``achieved'' by the best performing sources when
setting emission standards. As the D.C. Circuit has recognized, the
phrase ``average emissions limitation achieved by the best performing
12 percent of'' sources ``says nothing about how the performance of the
best units is to be calculated.'' Nat'l Ass'n of Clean Water Agencies
v. EPA, 734 F.3d 1115, 1141 (D.C. Cir. 2013). While the EPA accounts
for variability in setting emissions standards, nothing in CAA section
112 requires the Agency to consider malfunctions as part of that
analysis. A malfunction should not be treated in the same manner as the
type of variation in performance that occurs during routine operations
of a source. A malfunction is a failure of the source to perform in a
``normal or usual manner'' and no statutory language compels EPA to
consider such events in setting CAA section 112 standards.
Further, accounting for malfunctions in setting emission standards
would be difficult, if not impossible, given the myriad different types
of malfunctions that can occur across all sources in the category and
given the difficulties associated with predicting or accounting for the
frequency, degree, and duration of various malfunctions that might
occur. As such, the performance of units that are malfunctioning is not
``reasonably'' foreseeable. See, Sierra Club v. EPA, 167 F.3d 658, 662
(D.C. Cir. 1999) (``The EPA typically has wide latitude in determining
the extent of data-gathering necessary to solve a problem. We generally
defer to an agency's decision to proceed on the basis of imperfect
scientific information, rather than to `invest the resources to conduct
the perfect study.' '') See also, Weyerhaeuser v Costle, 590 F.2d 1011,
1058 (D.C. Cir. 1978) (``In the nature of things, no general limit,
individual permit, or even any upset provision can anticipate all upset
situations. After a certain point, the transgression of regulatory
limits caused by `uncontrollable acts of third parties,' such as
strikes, sabotage, operator intoxication or insanity, and a variety of
other eventualities, must be a matter for the administrative exercise
of case-by-case enforcement discretion, not for specification in
advance by regulation.''). In addition, emissions during a malfunction
event can be significantly higher than emissions at any other time of
source operation. For example, if an air pollution control device with
99-percent removal goes off-line as a result of a malfunction (as might
happen if, for example, the bags in a baghouse catch fire) and the
emission unit is a steady state type unit that would take days to shut
down, the source would go from 99-percent control to zero control until
the control device was repaired. The source's emissions during the
malfunction would be 100 times higher than during normal operations. As
such, the emissions over a 4-day malfunction period would exceed the
annual emissions of the source during normal operations. As this
example illustrates, accounting for malfunctions could lead to
standards that are not reflective of (and significantly less stringent
than) levels that are achieved by a well-performing non-malfunctioning
source. It is reasonable to interpret CAA section 112 to avoid such a
result. The EPA's approach to malfunctions is consistent with CAA
section 112 and is a reasonable interpretation of the statute.
In this instance, it is unlikely that a malfunction would result in
a violation of the standards for fermenters. For fermenters, the rule
provides an option for owners and operators to determine the average
VOC concentration for all batches within each fermentation stage using
data from 12-month periods. This option minimizes the effect of
malfunctions on the ability of a facility to meet the emission limits
because the averaging effectively minimizes ``spikes'' in emissions.
Additionally, many of the common malfunctions described by owners and
operators of nutritional yeast manufacturing facilities during the site
visits were malfunctions of the emissions
[[Page 95832]]
monitoring equipment. While the equipment was unable to record accurate
data during periods of malfunction, it did not impact actual emissions
because process controls could still be used to limit emissions.
In the unlikely event that a source fails to comply with the
applicable CAA section 112(d) standards as a result of a malfunction
event, the EPA would determine an appropriate response based on, among
other things, the good faith efforts of the source to minimize
emissions during malfunction periods, including preventative and
corrective actions, as well as root cause analyses to ascertain and
rectify excess emissions. The EPA would also consider whether the
source's failure to comply with the CAA section 112(d) standard was, in
fact, sudden, infrequent, not reasonably preventable and was not
instead caused in part by poor maintenance or careless operation. 40
CFR 63.2 (definition of malfunction).
If the EPA determines in a particular case that an enforcement
action against a source for violation of an emission standard is
warranted, the source can raise any and all defenses in that
enforcement action and the Federal District Court will determine what,
if any, relief is appropriate. The same is true for citizen enforcement
actions. Similarly, the presiding officer in an administrative
proceeding can consider any defense raised and determine whether
administrative penalties are appropriate.
In summary, the EPA interpretation of the CAA and, in particular,
CAA section 112 is reasonable and encourages practices that will avoid
malfunctions. Administrative and judicial procedures for addressing
exceedances of the standards fully recognize that violations may occur
despite good faith efforts to comply and can accommodate those
situations.\29\
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\29\ U.S. Sugar Corp. v. EPA, No. 11-1108, 2016 U.S. App. LEXIS
13783, at *41-49 (D.C. Cir. July 29, 2016) (upholding EPA's approach
to addressing periods of malfunction).
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a. 40 CFR 63.2150 General Duty
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.6(e)(1)(i) does
not apply to 40 CFR part 63, subpart CCCC. Section 63.6(e)(1)(i)
describes the general duty to minimize emissions. Some of the language
in that section is no longer necessary or appropriate in light of the
elimination of the SSM exemption. We are proposing instead to add
general duty regulatory text at 40 CFR 63.2150(c) that reflects the
general duty to minimize emissions while eliminating the reference to
periods covered by an SSM exemption. The current language in 40 CFR
63.6(e)(1)(i) characterizes what the general duty entails during
periods of SSM. With the elimination of the SSM exemption, there is no
need to differentiate between normal operations, startup and shutdown,
and malfunction events in describing the general duty. Therefore, the
language the EPA is proposing at 40 CFR 63.2150(c) does not include
that language from 40 CFR 63.6(e)(1).
We are also proposing to revise the General Provisions table (Table
6 to 40 CFR part 63, subpart CCCC) to specify that 40 CFR
63.6(e)(1)(ii) does not apply to 40 CFR part 63, subpart CCCC. Section
63.6(e)(1)(ii) imposes requirements that are not necessary with the
elimination of the SSM exemption or are redundant with the general duty
requirement being added at 40 CFR 63.2150.
b. SSM Plan
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.6(e)(3) does
not apply to 40 CFR part 63, subpart CCCC. Generally, these paragraphs
require development of an SSM plan and specify SSM recordkeeping and
reporting requirements related to the SSM plan. As noted, the EPA is
proposing to remove the SSM exemptions. Therefore, affected units will
be subject to an emission standard during such events. The
applicability of a standard during such events will ensure that sources
have ample incentive to plan for and achieve compliance and thus the
SSM plan requirements are no longer necessary.
c. Compliance With Standards
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.6(f)(1) does
not apply to 40 CFR part 63, subpart CCCC. The current language of 40
CFR 63.6(f)(1) exempts sources from non-opacity standards during
periods of SSM. As discussed above, the Court in Sierra Club vacated
the exemptions contained in this provision and held that the CAA
requires that some section 112 standard apply continuously. Consistent
with Sierra Club, the EPA is proposing standards in this rule that
apply at all times.
d. 40 CFR 63.2161 Performance Testing
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.7(e)(1) does
not apply to 40 CFR part 63, subpart CCCC. Section 63.7(e)(1) describes
performance testing requirements. The EPA is instead proposing to add a
performance testing requirement at 40 CFR 63.2161(b). The performance
testing requirements we are proposing to add differ from the General
Provisions performance testing provisions in several respects. The
proposed regulatory text does not include the language in 40 CFR
63.7(e)(1) that restated the SSM exemption and language that precluded
startup and shutdown periods from being considered ``representative''
for purposes of performance testing. The proposed performance testing
provisions exclude periods of startup and shutdown. As in 40 CFR
63.7(e)(1), performance tests conducted under this subpart should not
be conducted during malfunctions because conditions during malfunctions
are often not representative of normal operating conditions. The EPA is
proposing to add language that requires the owner or operator to record
the process information that is necessary to document operating
conditions during the test and include in such record an explanation to
support that such conditions represent normal operation. Section
63.7(e) requires that the owner or operator make available to the
Administrator such records ``as may be necessary to determine the
condition of the performance test'' upon request, but does not
specifically require the information to be recorded. The regulatory
text the EPA is proposing to add to this provision builds on that
requirement and makes explicit the requirement to record the
information.
e. Monitoring
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.8 (c)(1)(i) and
(iii) do not apply to 40 CFR part 63, subpart CCCC. The cross-
references to the general duty and SSM plan requirements in those
subparagraphs are not necessary in light of other requirements of 40
CFR 63.8 that require good air pollution control practices (40 CFR
63.8(c)(1)) and that set out the requirements of a quality control
program for monitoring equipment (40 CFR 63.8(d)).
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.8(d)(3) does
not apply to 40 CFR part 63, subpart CCCC. The final sentence in 40 CFR
63.8(d)(3) refers to the General Provisions' SSM plan requirement,
which is no longer
[[Page 95833]]
applicable. The EPA is proposing to add to the rule at 40 CFR
63.2182(b)(7) and 63.2183(d) text that contains the same requirements
as 40 CFR 63.8(d)(3), except that the final sentence is replaced with
the following sentence: ``The program of corrective action should be
included in the plan required under Sec. 63.8(d)(2).''
f. 40 CFR 63.2182 Recordkeeping
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(i)
does not apply to 40 CFR part 63, subpart CCCC. Section 63.10(b)(2)(i)
describes the recordkeeping requirements during startup and shutdown.
These recording provisions are no longer necessary because the EPA is
proposing that recordkeeping and reporting applicable to normal
operations will apply to startup and shutdown. In the absence of
special provisions applicable to startup and shutdown, such as a
startup and shutdown plan, there is no reason to retain additional
recordkeeping for startup and shutdown periods.
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(ii)
does not apply to 40 CFR part 63, subpart CCCC. Section 63.10(b)(2)(ii)
describes the recordkeeping requirements during a malfunction. The EPA
is proposing to add such requirements to 40 CFR 63.2182(a)(2). The
regulatory text we are proposing to add differs from the General
Provisions it is replacing in that the General Provisions requires the
creation and retention of a record of the occurrence and duration of
each malfunction of process, air pollution control, and monitoring
equipment. The EPA is proposing that this requirement apply to any
failure to meet an applicable standard and is requiring that the source
record the date, time, and duration of the failure rather than the
``occurrence.''
The EPA is also proposing to add to 40 CFR 63.2182(a)(2) a
requirement that sources keep records that include a list of the
affected source or equipment and actions taken to minimize emissions,
an estimate of the quantity of each regulated pollutant emitted over
the standard for which the source failed to meet the standard, and a
description of the method used to estimate the emissions. Examples of
such methods would include product-loss calculations, mass balance
calculations, measurements when available, or engineering judgment
based on known process parameters. The EPA is proposing to require that
sources keep records of this information to ensure that there is
adequate information to allow the EPA to determine the severity of any
failure to meet a standard, and to provide data that may document how
the source met the general duty to minimize emissions when the source
has failed to meet an applicable standard.
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(iv)
does not apply to 40 CFR part 63, subpart CCCC. When applicable, the
provision requires sources to record actions taken during SSM events
when actions were inconsistent with their SSM plan. The requirement is
no longer appropriate because SSM plans will no longer be required. The
requirement previously applicable under 40 CFR 63.10(b)(2)(iv)(B) to
record actions to minimize emissions and record corrective actions is
now applicable by reference to 40 CFR 63.2182(a)(2).
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(v)
does not apply to 40 CFR part 63, subpart CCCC. When applicable, the
provision requires sources to record actions taken during SSM events to
show that actions taken were consistent with their SSM plan. The
requirement is no longer appropriate because SSM plans will no longer
be required.
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(c)(15) does
not apply to 40 CFR part 63, subpart CCCC. When applicable, the
provision allows an owner or operator to use the affected source's SSM
plan or records kept to satisfy the recordkeeping requirements of the
SSM plan, specified in 40 CFR 63.6(e), to also satisfy the requirements
of 40 CFR 63.10(c)(10) through (12). The EPA is proposing to eliminate
this requirement because SSM plans would no longer be required, and,
therefore, 40 CFR 63.10(c)(15) no longer serves any useful purpose for
affected units.
g. 40 CFR 63.2181 Reporting
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(d)(5) does
not apply to 40 CFR part 63, subpart CCCC. Section 63.10(d)(5)
describes the reporting requirements for startups, shutdowns, and
malfunctions. To replace the General Provisions reporting requirement,
the EPA is proposing to add reporting requirements to 40 CFR
63.2181(c)(5) and (6). The replacement language differs from the
General Provisions requirement in that it eliminates periodic SSM
reports as a stand-alone report. We are proposing language that
requires sources that fail to meet an applicable standard at any time
to report the information concerning such events in the semi-annual
compliance report already required under this rule. We are proposing
that the report must contain the number, date, time, duration, and the
cause of such events (including unknown cause, if applicable), a list
of the affected source or equipment, an estimate of the quantity of
each regulated pollutant emitted over any emission limit, and a
description of the method used to estimate the emissions.
Examples of such methods would include product-loss calculations,
mass balance calculations, measurements when available, or engineering
judgment based on known process parameters. The EPA is proposing this
requirement to ensure that there is adequate information to determine
compliance, to allow the EPA to determine the severity of the failure
to meet an applicable standard, and to provide data that may document
how the source met the general duty to minimize emissions during a
failure to meet an applicable standard.
We will no longer require owners or operators to determine whether
actions taken to correct a malfunction are consistent with an SSM plan,
because malfunction plans would no longer be required. The proposed
amendments, therefore, eliminate the cross reference to 40 CFR
63.10(d)(5)(i) that contains the description of the previously required
SSM report format and submittal schedule from this section. These
specifications are no longer necessary because the events will be
reported in otherwise required reports with similar format and
submittal requirements.
We are proposing to revise the General Provisions table (Table 6 to
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(d)(5)(ii)
does not apply to 40 CFR part 63, subpart CCCC. Section 63.10(d)(5)(ii)
describes an immediate report for startups, shutdowns, and malfunctions
when a source failed to meet an applicable standard but did not follow
the SSM plan. We will no longer require owners and operators to report
when actions taken during a startup, shutdown, or malfunction were not
consistent with an SSM plan, because plans would no longer be required.
[[Page 95834]]
4. Rule Language Clarifications
We are proposing other miscellaneous revisions that add clarity to
rule language. For example, we are using active, second-person voice
throughout the rule by incorporating ``you must . . .'' into the
language. This is consistent with the EPA's current rule-writing
practices and creates uniformity within 40 CFR part 63, subpart CCCC.
We are also proposing the removal of ``but is not limited to'' in 40
CFR 63.2132, because this language is not necessary. The 40 CFR part
63, subpart CCCC requirements are limited to fermenters at this time,
and the removal of this language clarifies this distinction. The EPA
requests comment on each of these proposed revisions.
E. What compliance dates are we proposing?
The EPA is proposing that currently operating facilities must
immediately comply with the revised form of the fermenter VOC emission
limits and general compliance requirements upon the effective date of
the final rule. As discussed in section IV.D.2.a of this preamble,
facilities that currently demonstrate compliance by monitoring brew
ethanol in the fermenter have up to 1 year to install CEMS. During this
time, emissions data must be collected for each batch using the
existing compliance method (monitoring brew ethanol) for use in the
semiannual compliance reports with the revised emission limits. Sources
that are constructed or reconstructed after promulgation of the rule
revisions must comply with the emission limits and compliance
requirements upon startup of the affected source. We request comment on
each of these timeframes.
We are proposing to revise 40 CFR 63.2133 to specify that an area
source that becomes a major source of HAP, and that is an existing
affected source, must be in compliance with the subpart by not later
than 1 year after it becomes a major source, instead of by not later
than 3 years. This revision is consistent with the proposed requirement
that facilities have 1 year to install CEMS if they currently monitor
brew ethanol in the fermenter to determine compliance. The EPA requests
comment on this timeframe.
V. Summary of Cost, Environmental, and Economic Impacts
A. What are the affected sources?
We anticipate that four nutritional yeast facilities currently
operating in the United States will be affected by these proposed
amendments.
B. What are the air quality impacts?
The proposed amendments to this subpart will have a positive impact
on air quality. While facilities will not need to install additional
controls to comply with the proposed fermenter emission limits, the
revisions will remove the exemption that allowed up to 2 percent of the
total number of batches to exceed emission limits, as well as the
exemption that allowed emissions from batches produced during periods
of malfunction to not be used in determining compliance with emission
limits. While these changes cannot easily be quantified due to a lack
of data on the current number of exempted batches, the practical effect
is that production of all batches of nutritional yeast at affected
sources will be required to meet emission limits. The other proposed
revisions, which affect testing, monitoring, recordkeeping, and
reporting requirements, will ensure that emissions monitoring equipment
continues to perform as expected and provides reliable data from each
facility to be reported for compliance. For reference, the baseline
emissions for each facility are documented in the memorandum,
``Emissions Data and Acute Risk Factor Used in Residual Risk Modeling:
Manufacturing of Nutritional Yeast Source Category,'' which is
available in the docket for this action.
C. What are the cost impacts?
We have estimated compliance costs for all existing sources to
install the necessary monitoring equipment (i.e., VOC CEMS) and perform
annual RATAs for VOC CEMS. We estimated a total capital investment of
$511,000 and an annualized cost of approximately $172,000. The details
of the cost estimates are documented in the memorandum, ``Costs for the
Manufacturing of Nutritional Yeast Source Category,'' which is
available in the docket for this action.
D. What are the economic impacts?
Total annualized costs for this proposal are estimated to be
$172,000. Estimated annualized compliance costs range from $16,000 to
$109,000 per facility. The EPA conducted economic impact screening
analyses for this proposal, as detailed in the memorandum, ``Economic
Impact Analysis for the Manufacturing of Nutritional Yeast Risk and
Technology Review (RTR),'' which is available in the docket for this
action. Screening analyses suggest that the impacts of this action will
be minimal, with all entities subject to this action estimated to have
cost-to-sales ratios of less than 0.1 percent. We do not expect any
adverse economic impacts to result from this action.
E. What are the benefits?
As discussed above, the proposed amendments to this subpart will
have positive impacts on air quality by removing the exemption for a
portion of batches to meet emission limits. The proposed changes to
monitoring methods will increase the reliability of emissions data
collected by facilities by requiring continued maintenance of emission
monitoring systems and monitoring of actual emission measurements at
all times instead of allowing emission estimates based on brew ethanol
correlations, which will allow regulators to clearly assess whether the
standards for the protection of public health and the environment are
being met. In particular, the demographics analysis shows that
increased risk levels are concentrated around the facility that is not
currently using CEMS. The proposed amendment will directly benefit this
population by increasing the accuracy of the emissions data that is
monitored and reported. Utilization of CEMS is also expected to
facilitate more effective use of current process controls for
acetaldehyde emissions versus use of the brew ethanol correlation
approach. Other proposed amendments will result in additional benefits,
such as streamlined reporting through electronic methods for owners/
operators of nutritional yeast manufacturing facilities and increased
access to emissions data by stakeholders, as described in previous
sections.
VI. Request for Comments
We solicit comments on all aspects of this proposed action,
including those aspects specifically called out elsewhere in this
preamble. As noted previously, we are not seeking comment on the source
category definition in this action. In addition to general comments on
this proposed action, we are also interested in additional data that
may improve the risk assessments and other analyses. We are
specifically interested in receiving any improvements to the data used
in the site-specific emissions profiles used for risk modeling. Such
data should include supporting documentation in sufficient detail to
allow characterization of the quality and representativeness of the
data or information. Section VII of this preamble provides more
information on submitting data.
[[Page 95835]]
VII. Submitting Data Corrections
The site-specific emissions profiles used in the source category
risk and demographic analyses and instructions are available for
download on the RTR Web site at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html. The data files include detailed information for each HAP
emissions release point for the facilities in the source category.
If you believe that the data are not representative or are
inaccurate, please identify the data in question, provide your reason
for concern, and provide any ``improved'' data that you have, if
available. When you submit data, we request that you provide
documentation of the basis for the revised values to support your
suggested changes. To submit comments on the data downloaded from the
RTR Web site, complete the following steps:
1. Within this downloaded file, enter suggested revisions to the
data fields appropriate for that information.
2. Fill in the commenter information fields for each suggested
revision (i.e., commenter name, commenter organization, commenter email
address, commenter phone number, and revision comments).
3. Gather documentation for any suggested emissions revisions
(e.g., performance test reports, material balance calculations).
4. Send the entire downloaded file with suggested revisions in
Microsoft[supreg] Access format and all accompanying documentation to
Docket ID No. EPA-HQ-OAR-2015-0730 (through the method described in the
ADDRESSES section of this preamble).
5. If you are providing comments on a single facility or multiple
facilities, you need only submit one file for all facilities. The file
should contain all suggested changes for all sources at that facility.
We request that all data revision comments be submitted in the form of
updated Microsoft[supreg] Excel files that are generated by the
Microsoft[supreg] Access file. These files are provided on the RTR Web
site at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html.
VIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was,
therefore, not submitted to OMB for review.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA. The Information
Collection Request (ICR) that the EPA prepared has been assigned EPA
ICR number 1886.03. A copy of the ICR can be found in the docket for
this rule, and it is summarized here.
We are proposing new reporting and recordkeeping requirements to
the Manufacturing of Nutritional Yeast source category as a result of
additional requirements related to the use of CEMS.
Respondents/affected entities: Manufacturers of nutritional yeast.
Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart CCCC).
Estimated number of respondents: Four facilities.
Frequency of response: Initially and semiannually.
Total estimated burden: 1,340 hours (per year) for the responding
facilities and 117 hours (per year) for the Agency. Of these, 43 hours
(per year) for the responding facilities and 4 hours (per year) for the
Agency is the incremental burden to comply with the proposed rule
amendments. Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $939,000 (per year), which includes $832,000
annualized capital and operation and maintenance costs, for the
responding facilities and $5,400 (per year) for the Agency to comply
with all of the requirements in this NESHAP. Of the total, $175,000
(per year), including $172,000 in annualized capital and operation and
maintenance costs, for the responding facilities and $180 (per year)
for the Agency, is the incremental cost to comply with the proposed
amendments to this rule.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to the EPA using the docket identified at
the beginning of this rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs via email to
OIRA_submission@omb.eop.gov, Attention: Desk Officer for the EPA. Since
OMB is required to make a decision concerning the ICR between 30 and 60
days after receipt, OMB must receive comments no later than January 27,
2017. The EPA will respond to any ICR-related comments in the final
rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. One
entity subject to the requirements of this action is assumed to be a
small business for the purposes of this analysis, as the complex
ownership structure makes it difficult to clearly determine the
entity's size. The Agency has determined that this entity may
experience an impact of less than 0.01 percent of revenues. Details of
this analysis are presented in the memorandum, ``Economic Impact
Analysis for the Manufacturing of Nutritional Yeast Risk and Technology
Review (RTR),'' which is available in the docket for this action.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate that may result in
expenditures of $100 million or more as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. The action imposes no enforceable duty on any state,
local, or tribal governments. The nationwide annualized cost of this
action for affected industrial sources is estimated to be $172,000 per
year.
E. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175. No tribal facilities are known to be engaged in
the nutritional yeast manufacturing industry that would be affected by
this action. Thus, Executive Order 13175 does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866. This
action's
[[Page 95836]]
health and risk assessments are contained in sections III.A and B and
sections IV.A and B of this preamble.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR
Part 51
This action involves technical standards. Therefore, the EPA
conducted a search to identify potentially applicable voluntary
consensus standards. However, the Agency identified no such standards.
Therefore, the EPA has decided to use EPA Method 25A of 40 CFR part 60,
appendix A. A thorough summary of the search conducted and results are
included in the memorandum titled, ``Voluntary Consensus Standard
Results for the Risk and Technology Review of the Manufacturing of
Nutritional Yeast NESHAP,'' which is available in the docket for this
action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations.
The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (58 FR 7629, February 16, 1994).
The documentation for this decision is contained in section IV.A of
this preamble and the technical report, ``Risk and Technology Review--
Analysis of Socio-Economic Factors for Populations Living Near
Nutritional Yeast Manufacturing Facilities,'' which is available in the
docket for this action.
As discussed in section IV.A of this preamble, we performed a
demographic analysis, which is an assessment of risks to individual
demographic groups, of the population close to the facilities (within
50 km and within 5 km). In this analysis, we evaluated the distribution
of HAP-related cancer risks and non-cancer hazards from the nutritional
yeast manufacturing facilities across different social, demographic,
and economic groups within the populations living near facilities
identified as having the highest risks.
The analysis indicates that the minority population living within
50 km (1,700,000 people, of which 41 percent are minority) and within 5
km (131,567 people, of which 68 percent are minority) of the four
nutritional yeast manufacturing facilities is greater than the minority
population found nationwide (28 percent). The specific demographics of
the population within 5 and 50 km of the facilities indicate potential
disparities in certain demographic groups, including the ``African
American,'' ``Below the Poverty Level,'' and ``Over 25 and without high
school diploma'' groups.
When examining the risk levels of those exposed to emissions from
the four nutritional yeast manufacturing facilities we find
approximately 750 persons around one facility (AB Mauri--Fleischmann's
Yeast in Memphis, Tennessee) are exposed to a cancer risk greater than
or equal to 1-in-1 million with the highest exposure to these
individuals of less than 2-in-1 million. Of these 750 persons, 100
percent of them are defined as minority. When examining the noncancer
risks surrounding these facilities, no one is predicted to have a
chronic non-cancer TOSHI greater than 1. This facility is also the only
one that is not currently using CEMS. The proposed amendments will
directly benefit this population by increasing the accuracy of the
emissions data that is monitored and reported. Utilization of CEMS is
also expected to facilitate more effective use of process controls for
acetaldehyde emissions versus use of the brew ethanol correlation
approach.
The EPA has determined that this proposed rule does not have
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations, and/or
indigenous peoples because the health risks based on actual emissions
are low (below 2-in-1 million), the population exposed to risks greater
than 1-in-1 million is relatively small (750 persons), and the rule
maintains or increases the level of environmental protection for all
affected populations without having any disproportionately high and
adverse human health or environmental effects on any population,
including any minority, low-income, or indigenous populations. Further,
the EPA believes that implementation of this rule will provide an ample
margin of safety to protect public health of all demographic groups.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances, Incorporation by reference, Reporting and recordkeeping
requirements.
Dated: December 13, 2016.
Gina McCarthy,
Administrator.
For the reasons stated in the preamble, the Environmental
Protection Agency proposes to amend part 63 of title 40, chapter I, of
the Code of Federal Regulations as follows:
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES
0
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
Sec. 63.14 [Amended]
0
2. Section 63.14 is amended by adding paragraph (m)(24) to read as
follows:
* * * * *
(m) * * *
(24) EPA/600/R-12/531, EPA Traceability Protocol for Assay and
Certification of Gaseous Calibration Standards, May 2012, IBR approved
for Sec. 63.2163(b)(2).
* * * * *
0
3. Part 63 is amended by revising subpart CCCC to read as follows:
Subpart CCCC--National Emission Standards for Hazardous Air
Pollutants: Manufacturing of Nutritional Yeast
Contents
Sec.
What This Subpart Covers
63.2130 What is the purpose of this subpart?
63.2131 Am I subject to this subpart?
63.2132 What parts of my plant does this subpart cover?
63.2133 When do I have to comply with this subpart?
Emission Limitations
63.2140 What emission limitations must I meet?
General Compliance Requirements
63.2150 What are my general requirements for complying with this
subpart?
Testing and Initial Compliance Requirements
63.2160 By what date must I conduct an initial compliance
demonstration?
63.2161 What performance tests and other procedures must I use if I
monitor brew ethanol?
63.2162 When must I conduct subsequent performance tests?
63.2163 If I monitor fermenter exhaust, what are my monitoring
installation, operation, and maintenance requirements?
63.2164 If I monitor brew ethanol, what are my monitoring
installation, operation, and maintenance requirements?
[[Page 95837]]
63.2165 How do I demonstrate initial compliance with the emission
limitations if I monitor fermenter exhaust?
Continuous Compliance Requirements
63.2170 How do I monitor and collect data to demonstrate continuous
compliance?
63.2171 How do I demonstrate continuous compliance with the emission
limitations?
Notification, Reports, and Records
63.2180 What notifications must I submit and when?
63.2181 What reports must I submit and when?
63.2182 What records must I keep?
63.2183 In what form and how long must I keep my records?
Other Requirements and Information
63.2190 What parts of the General Provisions apply to me?
63.2191 Who implements and enforces this subpart?
63.2192 What definitions apply to this subpart?
Tables for Subpart CCCC
Table 1 to Subpart CCCC of Part 63--Emission Limitations
Table 2 to Subpart CCCC of Part 63--Requirements for Performance
Tests If You Monitor Brew Ethanol
Table 3 to Subpart CCCC of Part 63--Initial Compliance With Emission
Limitations
Table 4 to Subpart CCCC of Part 63--Continuous Compliance With
Emission Limitations
Table 5 to Subpart CCCC of Part 63--Requirements for Reports
Table 6 to Subpart CCCC of Part 63--Applicability of General
Provisions to Subpart CCCC
What This Subpart Covers
Sec. 63.2130 What is the purpose of this subpart?
This subpart establishes national emission limitations for
hazardous air pollutants emitted from manufacturers of nutritional
yeast. This subpart also establishes requirements to demonstrate
initial and continuous compliance with the emission limitations.
Sec. 63.2131 Am I subject to this subpart?
(a) You are subject to this subpart if you own or operate a
nutritional yeast manufacturing facility that is, is located at, or is
part of a major source of hazardous air pollutants (HAP) emissions.
(1) A manufacturer of nutritional yeast is a facility that makes
yeast for the purpose of becoming an ingredient in dough for bread or
any other yeast-raised baked product, or for becoming a nutritional
food additive intended for consumption by humans. A manufacturer of
nutritional yeast does not include production of yeast intended for
consumption by animals, such as an additive for livestock feed.
(2) A major source of HAP emissions is any stationary source or
group of stationary sources located within a contiguous area and under
common control that emits or has the potential to emit, considering
controls, any single HAP at a rate of 9.07 megagrams (10 tons) or more
per year or any combination of HAP at a rate of 22.68 megagrams (25
tons) or more per year.
(b) [Reserved]
Sec. 63.2132 What parts of my plant does this subpart cover?
(a) This subpart applies to each new, reconstructed, or existing
``affected source'' that produces Saccharomyces cerevisiae at a
nutritional yeast manufacturing facility.
(b) The affected source is the collection of equipment used in the
manufacture of the nutritional yeast species Saccharomyces cerevisiae.
This collection of equipment includes fermentation vessels
(fermenters), as described in paragraph (c) of this section. The
collection of equipment used in the manufacture of the nutritional
yeast species Candida utilis (torula yeast) is not part of the affected
source.
(c) The emission limitations in this subpart apply to fermenters in
the affected source that meet all of the criteria listed in paragraphs
(c)(1) and (2) of this section.
(1) The fermenters are ``fed-batch'' as defined in Sec. 63.2192.
(2) The fermenters are used to support one of the last three
fermentation stages in a production run (i.e., third-to-last stage,
second-to-last stage, and last stage), which may be referred to as
``stock, first generation, and trade,'' ``seed, semi-seed, and
commercial,'' or ``CB4, CB5, and CB6'' stages.
(d) The emission limitations in this subpart do not apply to flask,
pure-culture, yeasting-tank, or any other set-batch (defined in Sec.
63.2192) fermentation, and they do not apply to any operations after
the last dewatering operation, such as filtration.
(e) The emission limitations in Table 1 to this subpart do not
apply to fermenters during the production of specialty yeast (defined
in Sec. 63.2192).
(f) An affected source is a ``new affected source'' if you
commenced construction of the affected source after October 19, 1998,
and you met the applicability criteria in Sec. 63.2131 at the time you
commenced construction.
(g) An affected source is ``reconstructed'' if it meets the
criteria for reconstruction as defined in Sec. 63.2.
(h) An affected source is ``existing'' if it is not new or
reconstructed.
Sec. 63.2133 When do I have to comply with this subpart?
(a) If you have a new or reconstructed affected source, then you
must comply with paragraph (a)(1) or (2) of this section.
(1) If you start up your affected source before May 21, 2001, then
you must comply with the applicable emission limitations in Table 1 to
this subpart no later than May 21, 2001.
(2) If you start up your affected source on or after May 21, 2001,
then you must comply with the applicable emission limitations in Table
1 to this subpart upon startup of your affected source.
(b) If you have an existing affected source, then you must comply
with the applicable emission limitations in Table 1 to this subpart no
later than May 21, 2004.
(c) If you have an area source that increases its emissions, or its
potential to emit, so that it becomes a major source of HAP, then
paragraphs (c)(1) through (2) of this section apply.
(1) Any portion of the existing facility that is a new affected
source or a new reconstructed source must be in compliance with this
subpart upon startup.
(2) All other parts of the affected source must be in compliance
with this subpart by not later than 1 year after it becomes a major
source.
(d) You must meet the notification requirements in Sec. 63.2180
according to the schedule in Sec. 63.2180 and in subpart A of this
part.
Emission Limitations
Sec. 63.2140 What emission limitations must I meet?
You must meet the applicable emission limitations in Table 1 to
this subpart.
General Compliance Requirements
Sec. 63.2150 What are my general requirements for complying with this
subpart?
(a) You must be in compliance with the emission limitations in
Table 1 to this subpart at all times.
(b) If the date upon which you must demonstrate initial compliance
as specified in Sec. 63.2160 falls after the compliance date specified
for your affected source in Sec. 63.2133, then you must maintain a log
detailing the operation and maintenance of the continuous emission
monitoring systems and the process and emissions control equipment
during the period between those dates.
(c) At all times, you must operate and maintain any affected
source, including associated air pollution control
[[Page 95838]]
equipment and monitoring equipment, in a manner consistent with safety
and good air pollution control practices for minimizing emissions. The
general duty to minimize emissions does not require you to make any
further efforts to reduce emissions if levels required by the
applicable standard have been achieved. Determination of whether an
affected source is operating in compliance with operation and
maintenance requirements will be based on information available to the
Administrator that may include, but is not limited to, monitoring
results, review of operation and maintenance procedures, review of
operation and maintenance records, and inspection of the affected
source.
(d) To determine compliance before [date of publication of the
final rule in the Federal Register], you must monitor the volatile
organic compound (VOC) concentration or brew ethanol continuously for
each batch and demonstrate that the VOC concentration for at least 98
percent of the batches for each fermentation stage in each 12-month
calculation period does not exceed the applicable emission limitations
in Table 1 to this subpart. You must monitor VOC concentration either
by installing and operating a continuous emission monitoring system
(CEMS) to monitor VOC in the fermenter exhaust continuously or by
monitoring the concentration of ethanol in the fermenter liquid
continuously for each batch (i.e., brew ethanol monitoring) and
determining VOC concentration in the exhaust using the correlation
equation developed according to Sec. 63.2161.
(e) To determine compliance on or after [date of publication of the
final rule in the Federal Register], you must monitor VOC concentration
continuously for each batch and demonstrate compliance with the
applicable emission limitations of either the Average Option or the
Batch Option in Table 1 to this subpart. You must monitor VOC
concentration by installing and operating a CEMS to monitor the VOC
concentration in the fermenter exhaust continuously.
Testing and Initial Compliance Requirements
Sec. 63.2160 By what date must I conduct an initial compliance
demonstration?
(a) For each emission limitation in Table 1 to this subpart for
which you demonstrate compliance using the Average Option, you must
demonstrate initial compliance for the period ending on the last day of
the month that is 12 calendar months (or 11 calendar months, if the
compliance date for your affected source is the first day of the month)
after the compliance date that is specified for your affected source in
Sec. 63.2133. (For example, if the compliance date is October 15,
2017, then the first 12-month period for which you must demonstrate
compliance would be October 15, 2017 through October 31, 2018.)
(b) For each emission limitation in Table 1 to this subpart for
which you demonstrate compliance using the Batch Option, you must
demonstrate initial compliance for the period ending June 30 or
December 31 (use whichever date is the first date following the
compliance date that is specified for your affected source in Sec.
63.2133).
Sec. 63.2161 What performance tests and other procedures must I use
if I monitor brew ethanol?
(a) You must conduct each performance test in Table 2 to this
subpart that applies to you, as specified in paragraphs (b) through (f)
of this section.
(b) You must conduct performance tests under such conditions as the
Administrator specifies, based on representative performance of the
affected source for the period being tested, and under the specific
conditions that this subpart specifies in Table 2 to this subpart and
in paragraphs (b)(1) through (4) of this section. You must record the
process information that is necessary to document operating conditions
during the test and include in such record an explanation to support
that such conditions represent normal operation. Upon request, you must
make available to the Administrator such records as may be necessary to
determine the conditions of performance tests.
(1) You must conduct each performance test simultaneously with brew
ethanol monitoring to establish a brew-to-exhaust correlation as
specified in paragraph (f) of this section.
(2) For each fermentation stage, you must conduct one run of the
EPA Test Method 25A of 40 CFR part 60, appendix A-7, over the entire
length of a batch. The three fermentation stages do not have to be from
the same production run.
(3) You must obtain your test sample at a point in the exhaust-gas
stream before you inject any dilution air. For fermenters, dilution air
is any air not needed to control fermentation.
(4) You must record the results of the test for each fermentation
stage.
(c) You may not conduct performance tests during periods of
malfunction.
(d) You must collect data to correlate the brew ethanol
concentration to the VOC concentration in the fermenter exhaust
according to paragraphs (d)(1) through (3) of this section.
(1) You must collect a separate set of brew ethanol concentration
data for each fed-batch fermentation stage while manufacturing the
product that constitutes the largest percentage (by mass) of average
annual production.
(2) You must measure brew ethanol as specified in Sec. 63.2164
concurrently with conducting a performance test for VOC in fermenter
exhaust as specified in paragraph (b) of this section. You must measure
brew ethanol at least once during each successive 30-minute period over
the entire period of the performance test for VOC in fermenter exhaust.
(3) You must keep a record of the brew ethanol concentration data
for each fermentation stage over the period of EPA Test Method 25A of
40 CFR part 60, appendix A-7, performance test.
(e) For each set of data that you collected under paragraphs (b)
and (d) of this section, you must perform a linear regression of brew
ethanol concentration (percent) on VOC fermenter exhaust concentration
(parts per million by volume (ppmv) measured as propane). You must
ensure the correlation between the brew ethanol concentration, as
measured by the brew ethanol monitor, and the VOC fermenter exhaust
concentration, as measured by EPA Test Method 25A of 40 CFR part 60,
appendix A-7, is linear with a correlation coefficient of at least
0.90.
(f) You must calculate the VOC concentration in the fermenter
exhaust using the brew ethanol concentration data according to Equation
1 of this section.
BAVOC = BAE * CF + y (Eq. 1)
Where:
BAVOC = Batch-average concentration of VOC in fermenter exhaust
(ppmv measured as propane), calculated for compliance demonstration
BAE = Batch-average concentration of brew ethanol in fermenter
liquid (percent), measured by the brew ethanol monitor
CF = Constant established at performance test and representing the
slope of the regression line
Y = Constant established at performance test and representing the y-
intercept of the regression line
Sec. 63.2162 When must I conduct subsequent performance tests?
(a) For each emission limitation in Table 1 to this subpart for
which compliance is demonstrated by monitoring brew ethanol
concentration and calculating VOC concentration in the fermenter
exhaust according to the
[[Page 95839]]
procedures in Sec. 63.2161, you must conduct an EPA Test Method 25A of
40 CFR part 60, appendix A-7, performance test and establish a brew-to-
exhaust correlation according to the procedures in Table 2 to this
subpart and in Sec. 63.2161, at least once every year.
(b) The first subsequent performance test must be conducted no
later than 365 calendar days after the initial performance test
conducted according to Sec. 63.2160. Each subsequent performance test
must be conducted no later than 365 calendar days after the previous
performance test. You must conduct a performance test for each 365
calendar day period during which you demonstrate compliance using the
brew ethanol correlation developed according to Sec. 63.2161.
Sec. 63.2163 If I monitor fermenter exhaust, what are my monitoring
installation, operation, and maintenance requirements?
(a) You must install and certify a CEMS that generates a single
combined response value for VOC concentration (VOC CEMS) according to
the procedures and requirements in Performance Specification 8--
Performance Specifications for Volatile Organic Compound Continuous
Emission Monitoring Systems in Stationary Sources in appendix B to part
60 of this chapter.
(b) You must operate and maintain your VOC CEMS according to the
procedures and requirements in Procedure 1--Quality Assurance
Requirements for Gas Continuous Emission Monitoring Systems Used for
Compliance Determination in appendix F to part 60 of this chapter.
(1) You must conduct a relative accuracy test audit (RATA) at least
annually, in accordance with sections 8 and 11, as applicable, of
Performance Specification 8.
(2) As necessary, rather than relying on reference 2 of Performance
Specification 8 of appendix B to 40 CFR part 60, you must rely on EPA/
600/R-12/531, EPA Traceability Protocol for Assay and Certification of
Gaseous Calibration Standards, May 2012 (incorporated by reference, see
Sec. 63.14).
(3) Your affected source must meet the criteria of Performance
Specification 8, section 13.2.
(c) You must use Method 25A in appendix A-7 to part 60 of this
chapter as the Reference Method (RM).
(d) You must calibrate your VOC CEMS with propane.
(e) You must set your VOC CEMS span at less than 5 times the
relevant VOC emission limitation given in Table 1 or 2 of this subpart.
Note that the EPA considers 1.5 to 2.5 times the relevant VOC emission
limitation to be the optimum range, in general.
(f) You must complete the performance evaluation and submit the
performance evaluation report before the compliance date that is
specified for your affected source in Sec. 63.2133.
(g) You must monitor VOC concentration in fermenter exhaust at any
point prior to dilution of the exhaust stream.
(h) You must collect data using the VOC CEMS at all times during
each batch monitoring period, except for periods of monitoring system
malfunctions, required monitoring system quality assurance or quality
control activities (including, as applicable, calibration checks and
required zero and span adjustments), and any scheduled maintenance.
(i) For each CEMS, you must record the results of each inspection,
calibration, and validation check.
(j) You must check the zero (low-level) and high-level calibration
drifts for each CEMS in accordance with the applicable Performance
Specification of 40 CFR part 60, appendix B. You must adjust the zero
(low-level) and high-level calibration drifts, at a minimum, whenever
the zero (low-level) drift exceeds 2 times the limits of the applicable
Performance Specification. You must perform the calibration drift
checks at least once daily except under the conditions of paragraphs
(j)(1) through (3) of this section.
(1) If a 24-hour calibration drift check for your CEMS is performed
immediately prior to, or at the start of, a batch monitoring period of
a duration exceeding 24 hours, you are not required to perform 24-hour-
interval calibration drift checks during that batch monitoring period.
(2) If the 24-hour calibration drift exceeds 2.5 percent of the
span value in fewer than 5 percent of the checks over a 1-month period,
and the 24-hour calibration drift never exceeds 7.5 percent of the span
value, you may reduce the frequency of calibration drift checks to at
least weekly (once every 7 days).
(3) If, during two consecutive weekly checks, the weekly
calibration drift exceeds 5 percent of the span value, then you must
resume a frequency of at least 24-hour interval calibration checks
until the 24-hour calibration checks meet the test of paragraph (j)(2)
of this section.
(k) If your CEMS is out of control, you must take corrective action
according to paragraphs (k)(1) through (3) of this section.
(1) Your CEMS is out of control if the zero (low-level) or high-
level calibration drift exceeds 2 times the limits of the applicable
Performance Specification.
(2) When the CEMS is out of control, you must take the necessary
corrective action and repeat all necessary tests that indicate that the
system is out of control. You must take corrective action and conduct
retesting until the performance requirements are below the applicable
limits.
(3) You must not use data recorded during batch monitoring periods
in which the CEMS is out of control in averages and calculations used
to demonstrate compliance, or to meet any data availability requirement
established under this subpart. The beginning of the out-of-control
period is the beginning of the first batch monitoring period that
follows the most recent calibration drift check during which the system
was within allowable performance limits. The end of the out-of-control
period is the end of the last batch monitoring period before you have
completed corrective action and successfully demonstrated that the
system is within the allowable limits. If your successful demonstration
that the system is within the allowable limits occurs during a batch
monitoring period, then the out-of-control period ends at the end of
that batch monitoring period. If the CEMS is out of control for any
part of a particular batch monitoring period, it is out of control for
the whole batch monitoring period.
Sec. 63.2164 If I monitor brew ethanol, what are my monitoring
installation, operation, and maintenance requirements?
(a) You must install, operate, and maintain each brew ethanol
monitor according to the manufacturer's specifications and in
accordance with Sec. 63.2150(c).
(b) Each of your brew ethanol monitors must complete a minimum of
one cycle of operation (sampling, analyzing, and data recording) for
each successive 30-minute period within each batch monitoring period.
Except as specified in paragraph (c) of this section, you must have a
minimum of two cycles of operation in a 1-hour period to have a valid
hour of data.
(c) You must reduce the brew ethanol monitor data to arithmetic
batch averages computed from two or more data points over each 1-hour
period, except during periods when calibration, quality assurance, or
maintenance activities pursuant to provisions of this part are being
performed. During these periods, a valid hour of data must consist of
at least one data point representing a 30-minute period.
[[Page 95840]]
(d) You must have valid brew ethanol monitor data from all
operating hours over the entire batch monitoring period.
(e) You must set the brew ethanol monitor span to correspond to not
greater than 5 times the relevant emission limit; note that we consider
1.5 to 2.5 times the relevant emission limit to be the optimum range,
in general. You must use the brew-to-exhaust correlation equation
established under Sec. 63.2161(f) to determine the span value for your
brew ethanol monitor that corresponds to the relevant emission limit.
(f) For each brew ethanol monitor, you must record the results of
each inspection, calibration, and validation check.
(g) The gas chromatographic (GC) that you use to calibrate your
brew ethanol monitor must meet the requirements of paragraphs (g)(1)
through (3) of this section.
(1) You must calibrate the GC at least daily, by analyzing standard
solutions of ethanol in water (0.05 percent, 0.15 percent, and 0.3
percent).
(2) For use in calibrating the GC, you must prepare the standard
solutions of ethanol using the procedures listed in paragraphs
(g)(2)(i) through (vi) of this section.
(i) Starting with 100-percent ethanol, you must dry the ethanol by
adding a small amount of anhydrous magnesium sulfate (granular) to 15-
20 milliliters (ml) of ethanol.
(ii) You must place approximately 50 ml of water into a 100-ml
volumetric flask and place the flask on a balance. You must tare the
balance. You must weigh 2.3670 grams of the dry (anhydrous) ethanol
into the volumetric flask.
(iii) Add the 100-ml volumetric flask contents to a 1000-ml
volumetric flask. You must rinse the 100-ml volumetric flask with water
into the 1000-ml flask. You must bring the volume to 1000 ml with
water.
(iv) You must place an aliquot into a sample bottle labeled ``0.3%
Ethanol.''
(v) You must fill a 50-ml volumetric flask from the contents of the
1000-ml flask. You must add the contents of the 50-ml volumetric flask
to a 100-ml volumetric flask and rinse the 50-ml flask into the 100-ml
flask with water. You must bring the volume to 100 ml with water. You
must place the contents into a sample bottle labeled ``0.15% Ethanol.''
(vi) With a 10-ml volumetric pipette, you must add two 10.0-ml
volumes of water to a sample bottle labeled ``0.05% Ethanol.'' With a
10.0-ml volumetric pipette, you must pipette 10.0 ml of the 0.15
percent ethanol solution into the sample bottle labeled ``0.05%
Ethanol.''
(3) For use in calibrating the GC, you must dispense samples of the
standard solutions of ethanol in water in aliquots to appropriately
labeled and dated glass sample bottles fitted with caps having a
Teflon[supreg] seal. You may keep refrigerated samples unopened for 1
month. You must prepare new calibration standards of ethanol in water
at least monthly.
(h) You must calibrate the CEMS according to paragraphs (h)(1)
through (3) of this section.
(1) To calibrate the brew ethanol monitor, you must inject a brew
sample into a calibrated GC and compare the simultaneous ethanol value
given by the brew ethanol monitor to that given by the GC. You must use
either the Porapak[supreg] Q, 80-100 mesh, 6' x \1\8',
stainless steel packed column or the DB Wax, 0.53 millimeter x 30 meter
capillary column.
(2) If a brew ethanol monitor value for ethanol differs by 20
percent or more from the corresponding GC ethanol value, you must
determine the brew ethanol values throughout the rest of the batch
monitoring period by injecting brew samples into the GC not less
frequently than once every 30 minutes. From the time at which you
detect a difference of 20 percent or more until the batch monitoring
period ends, the GC data will serve as the brew ethanol monitor data.
(3) You must perform a calibration of the brew ethanol monitor at
least four times per batch.
Sec. 63.2165 How do I demonstrate initial compliance with the
emission limitations if I monitor fermenter exhaust?
(a) You must demonstrate initial compliance with each emission
limitation that applies to you according to Table 3 to this subpart.
(b) You must submit the Notification of Compliance Status
containing the results of the initial compliance demonstration
according to the requirements in Sec. 63.2180(e).
Continuous Compliance Requirements
Sec. 63.2170 How do I monitor and collect data to demonstrate
continuous compliance?
(a) You must monitor and collect data according to this section.
(b) Except for periods of monitoring system malfunctions, required
monitoring system quality assurance or control activities (including,
as applicable, calibration checks and required zero and span
adjustments), and any scheduled maintenance, you must collect data
using the CEMS at all times during each batch monitoring period.
(c) You may not use data recorded during monitoring malfunctions,
associated repairs, and required quality assurance or quality control
activities in data averages and calculations used to report emission or
operating levels, or to fulfill a data collection requirement. You must
use all the data collected during all other periods in assessing the
operation of the control system.
(d) Any hour during the batch monitoring period for which quality-
assured VOC data are not obtained is a deviation from monitoring
requirements and is counted as an hour of monitoring system downtime.
Sec. 63.2171 How do I demonstrate continuous compliance with the
emission limitations?
(a) You must demonstrate continuous compliance with each emission
limitation in Table 1 to this subpart that applies to you according to
methods specified in Table 4 to this subpart and the applicable
procedures of this section.
(1) To demonstrate compliance prior to [date one year after the
date of publication of the final rule in the Federal Register], you
must install, operate, and maintain a CEMS in accordance with Sec.
63.2163 to monitor VOC concentration in the fermenter exhaust or
install, operate, and maintain a brew ethanol monitor in accordance
with Sec. 63.2164 to monitor the brew ethanol concentration in the
fermenter liquid.
(2) To demonstrate compliance on and after [date 1 year after the
date of publication of the final rule in the Federal Register], you
must install, operate, and maintain a CEMS in accordance with Sec.
63.2163 to monitor VOC concentration in the fermenter exhaust.
(b) To demonstrate compliance with emission limitations prior to
[date of publication of the final rule in the Federal Register], you
must calculate the percentage of within-concentration batches (defined
in Sec. 63.2192) for each 12-month calculation period by following the
procedures in paragraphs (b)(1) through (4) of this section.
(1) You must determine the percentage of batches over a 12-month
calculation period that were in compliance with the applicable maximum
concentration. The total number of batches in the calculation period is
the sum of the numbers of batches of each fermentation stage for which
emission limits apply. To determine which batches are in the 12-month
calculation period, you must
[[Page 95841]]
include those batches for which the batch monitoring period ended on or
after midnight on the first day of the period and exclude those batches
for which the batch monitoring period did not end before midnight on
the last day of the period.
(2) You must determine the percentage of batches in compliance with
the applicable emission limitations for each 12-month calculation
period at the end of each calendar month.
(3) The first 12-month calculation period begins on the compliance
date that is specified for your affected source in Sec. 63.2133 and
ends on the last day of the month that includes the date 1 year after
your compliance date, unless the compliance date for your affected
source is the first day of the month, in which case the first 12-month
calculation period ends on the last day of the month that is 11
calendar months after the compliance date. (For example, if the
compliance date for your affected source is October 15, 2017, the first
12-month calculation period would begin on October 15, 2017, and end on
October 31, 2018. If the compliance date for your affected source is
October 1, 2017, the first 12-month calculation period would begin on
October 1, 2017, and end on September 30, 2018.)
(4) The second 12-month calculation period and each subsequent 12-
month calculation period begins on the first day of the month following
the first full month of the previous 12-month averaging period and ends
on the last day of the month 11 calendar months later. (For example, if
the compliance date for your affected source is October 15, 2017, the
second calculation period would begin on December 1, 2017, and end on
November 30, 2018.)
(c) To demonstrate compliance with emission limitations on and
after [date of publication of the final rule in the Federal Register]
by using the Average Option, you must follow the procedures in
paragraphs (c)(1) through (3) of this section.
(1) At the end of each calendar month, you must determine the
average VOC concentration from all batches in each fermentation stage
in a 12-month calculation period. To determine which batches are in a
12-month calculation period, you must include those batches for which
the batch monitoring period ended on or after midnight on the first day
of the period and exclude those batches for which the batch monitoring
period did not end before midnight on the last day of the period.
(2) The first 12-month calculation period begins on the compliance
date that is specified for your affected source in Sec. 63.2133 and
ends on the last day of the month that includes the date 1 year after
your compliance date, unless the compliance date for your affected
source is the first day of the month, in which case the first 12-month
calculation period ends on the last day of the month that is 11
calendar months after the compliance date. (For example, if the
compliance date for your affected source is October 15, 2017, the first
12-month calculation period would begin on October 15, 2017, and end on
October 31, 2018. If the compliance date for your affected source is
October 1, 2017, the first 12-month calculation period would begin on
October 1, 2017, and end on September 30, 2018.)
(3) The second 12-month calculation period and each subsequent 12-
month calculation period begins on the first day of the month following
the first full month of the previous 12-month averaging period and ends
on the last day of the month 11 calendar months later. (For example, if
the compliance date for your affected source is October 15, 2017, the
second calculation period would begin on December 1, 2017, and end on
November 30, 2018.)
(d) To demonstrate compliance with emission limitations on and
after [date of publication of the final rule in the Federal Register]
by using the Batch Option, you must determine the average VOC
concentration in the fermenter exhaust for each batch of each
fermentation stage in a semiannual reporting period (i.e., January 1
through June 30 or July 1 through December 31). To determine which
batches are in the semiannual reporting period, you must include those
batches for which the batch monitoring period ended on or after
midnight on the first day of the period and exclude those batches for
which the batch monitoring period did not end before midnight on the
last day of the period.
Notification, Reports, and Records
Sec. 63.2180 What notifications must I submit and when?
(a) You must submit all of the notifications in Sec. Sec. 63.7(b)
and (c), 63.8(e), (f)(4) and (6), and 63.9(b) through (h) that apply to
you by the dates specified.
(b) If you start up your affected source before May 21, 2001, you
are not subject to the initial notification requirements of Sec.
63.9(b)(2).
(c) If you are required to conduct a performance test as specified
in Table 2 to this subpart, you must submit a notification of intent to
conduct a performance test at least 60 calendar days before the
performance test is scheduled to begin as required in Sec. 63.7(b)(1).
(d) If you are required to conduct a performance evaluation as
specified in Sec. 63.2163, you must submit a notification of the date
of the performance evaluation at least 60 days prior to the date the
performance evaluation is scheduled to begin as required in Sec.
63.8(e)(2).
(e) If you are required to conduct a performance test as specified
in Table 2 to this subpart, you must submit a Notification of
Compliance Status according to Sec. 63.9(h)(2)(ii).
(f) For each initial compliance demonstration required in Table 3
to this subpart, you must submit the Notification of Compliance Status
no later than July 31 or January 31, whichever date follows the date
that is specified for your affected source in Sec. 63.2160(a) or (b).
The first compliance report, described in Sec. 63.2181(b)(1), serves
as the Notification of Compliance Status.
Sec. 63.2181 What reports must I submit and when?
(a) You must submit each report in Table 5 to this subpart that
applies to you.
(1) On and after [date of publication of the final rule in the
Federal Register], you must also comply with electronic reporting for
compliance tests as specified in paragraphs (a)(1)(i) and (ii) of this
section.
(i) Within 60 days after the date of completing each performance
test as required by this subpart, you must submit the results of the
performance test following the procedure specified in either paragraph
(a)(1)(i)(A) or (B) of this section.
(A) For data collected using test methods supported by the EPA's
Electronic Reporting Tool (ERT) as listed on the EPA's ERT Web site
(https://www3.epa.gov/ttn/chief/ert/ert_info.html) at the time of the
test, you must submit the results of the performance test to the EPA
via the Compliance and Emissions Data Reporting Interface (CEDRI).
(CEDRI can be accessed through the EPA's Central Data Exchange (CDX)
(https://cdx.epa.gov/).) Performance test data must be submitted in a
file format generated through the use of the EPA's ERT or an alternate
electronic file format consistent with the extensible markup language
(XML) schema listed on the EPA's ERT Web site. If you claim that some
of the performance test information being submitted is confidential
business information (CBI), then you must submit a complete file
generated through the use of the EPA's ERT or an alternate electronic
file consistent with the XML schema listed
[[Page 95842]]
on the EPA's ERT Web site, including information claimed to be CBI, on
a compact disc, flash drive or other commonly used electronic storage
media to the EPA. The electronic media must be clearly marked as CBI
and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader,
Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC
27703. The same ERT or alternate file with the CBI omitted must be
submitted to the EPA via the EPA's CDX as described earlier in this
paragraph.
(B) For data collected using test methods that are not supported by
the EPA's ERT as listed on the EPA's ERT Web site at the time of the
test, you must submit the results of the performance test to the
Administrator at the appropriate address listed in Sec. 63.13.
(ii) Within 60 days after the date of completing each CEMS
performance evaluation (as defined in Sec. 63.2), you must submit the
results of the performance evaluation following the procedure specified
in either paragraph (ii)(A) or (B) of this section.
(A) For performance evaluations of CEMS measuring RATA pollutants
that are supported by the EPA's ERT as listed on the EPA's ERT Web site
at the time of the evaluation, you must submit the results of the
performance evaluation to the EPA via the CEDRI. Performance evaluation
data must be submitted in a file format generated through the use of
the EPA's ERT or an alternate file format consistent with the XML
schema listed on the EPA's ERT Web site. If you claim that some of the
performance evaluation information being submitted is CBI, then you
must submit a complete file generated through the use of the EPA's ERT
or an alternate electronic file consistent with the XML schema listed
on the EPA's ERT Web site, including information claimed to be CBI, on
a compact disc, flash drive or other commonly used electronic storage
media to the EPA. The electronic storage media must be clearly marked
as CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group
Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd.,
Durham, NC 27703. The same ERT or alternate file with the CBI omitted
must be submitted to the EPA via the EPA's CDX as described earlier in
this paragraph.
(B) For any performance evaluations of continuous emission
monitoring systems measuring RATA pollutants that are not supported by
the EPA's ERT as listed on the EPA's ERT Web site at the time of the
evaluation, you must submit the results of the performance evaluation
to the Administrator at the appropriate address listed in Sec. 63.13.
(b) Unless the Administrator has approved a different schedule for
submission of reports under Sec. 63.10(a), you must submit each report
by the date in Table 5 to this subpart and according to paragraphs
(b)(1) through (5) of this section.
(1) The first compliance report must include the information
specified in paragraph (c) of this section. If you are demonstrating
compliance with an emission limitation using a 12-month calculation
period (e.g., the Average Option), then the first compliance report
must cover the period beginning on the compliance date that is
specified for your affected source in Sec. 63.2133 and ending on
either June 30 or December 31 (use whichever date is the first date
following the end of the first 12 calendar months after the compliance
date that is specified for your affected source in Sec. 63.2133). (For
example, if the compliance date for your affected source is October 15,
2017, then the first compliance report would cover the period from
October 15, 2017 to December 31, 2018.) If you are demonstrating
compliance with an emission limitation using the Batch Option, then the
first compliance report must cover the period beginning on the
compliance date that is specified for your affected source in Sec.
63.2133 and ending on either June 30 or December 31 (use whichever date
is the first date following the compliance date that is specified for
your affected source in Sec. 63.2133).
(2) The first compliance report must be postmarked or delivered no
later than July 31 or January 31, whichever date follows the end of the
first compliance reporting period specified in paragraph (b)(1) of this
section.
(3) Each subsequent compliance report must cover the semiannual
reporting period from January 1 through June 30 or the semiannual
reporting period from July 1 through December 31. Each subsequent
compliance report must include the information specified in paragraph
(c) of this section.
(4) Each subsequent compliance report must be postmarked or
delivered no later than July 31 or January 31, whichever date is the
first date following the end of the semiannual reporting period.
(5) For each affected source that is subject to permitting
regulations pursuant to 40 CFR part 70 or part 71, and if the
permitting authority has established dates for submitting semiannual
reports pursuant to 40 CFR 70.6(a)(3)(a)(iii)(A) or 40 CFR
71.6(a)(3)(a)(iii)(A), you may submit the first and subsequent
compliance reports according to the dates the permitting authority has
established instead of according to the dates in paragraphs (b)(1)
through (4) of this section.
(c) The compliance report must contain the information listed in
paragraphs (c)(1) through (7) of this section.
(1) Company name and address.
(2) Statement by a responsible official with that official's name,
title, and signature, certifying the accuracy of the content of the
report.
(3) Date of report and beginning and ending dates of the reporting
period.
(4) For reporting periods ending before [date of publication of the
final rule in the Federal Register], the percentage of batches that are
within-concentration batches for each 12-month period ending on a
calendar month that falls within the reporting period.
(5) For reporting periods ending before [date of publication of the
final rule in the Federal Register], if an affected source fails to
meet an applicable standard, the information for each batch for which
the batch-average VOC concentration exceeded the applicable maximum VOC
concentration in Table 1 to this subpart and whether the batch was in
production during a period of malfunction or during another period.
(6) For reporting periods ending on or after [date of publication
of the final rule in the Federal Register], if an affected source meets
an applicable standard, the information in paragraph (c)(6)(i) or (ii)
of this section, depending on the compliance option selected from Table
1 to this subpart.
(i) If using the Average Option in Table 1 to this subpart, the
average VOC concentration in the fermenter exhaust from all batches in
each fermentation stage for each 12-month period ending on a calendar
month that falls within the reporting period that did not exceed the
applicable emission limitation.
(ii) If using the Batch Option in Table 1 to this subpart, a
certification that the average VOC concentration in the fermenter
exhaust for each batch did not exceed applicable emission limitations.
(7) For reporting periods ending on and after [date of publication
of the final rule in the Federal Register], if an affected source fails
to meet an applicable standard, the information in paragraph (c)(7)(i)
or (ii) of this section, depending on the compliance option selected
from Table 1 to this subpart.
(i) If using the Average Option in Table 1 to this subpart, the
average VOC concentration in the fermenter exhaust from all batches in
each fermentation
[[Page 95843]]
stage for each 12-month period that failed to meet the applicable
standard, the fermenters that operated in each fermentation stage that
failed to meet the applicable standard, the duration of each failure,
an estimate of the quantity of VOC emitted over the emission
limitation, a description of the method used to estimate the emissions,
and the actions taken to minimize emissions and correct the failure.
(ii) If using the Batch Option in Table 1 to this subpart, the
fermenters and batches that failed to meet the applicable standard; the
date, time, and duration of each failure; an estimate of the quantity
of VOC emitted over the emission limitation; a description of the
method used to estimate the emissions; and the actions taken to
minimize emissions and correct the failure.
(8) The total operating hours and hours of monitoring system
downtime for each fermenter.
Sec. 63.2182 What records must I keep?
(a) You must keep the records listed in paragraphs (a)(1) through
(4) of this section.
(1) A copy of each notification and report that you submitted to
comply with this subpart, including all documentation supporting any
Notification of Compliance Status and compliance report that you
submitted, according to the requirements in Sec. 63.10(b)(2)(xiv).
(2) Records of failures to meet a standard, specified in Sec.
63.2181(c)(5) and (7).
(3) Records of performance tests and performance evaluations as
required in Sec. 63.10(b)(2)(viii).
(4) Records of results of brew-to-exhaust correlation tests
specified in Sec. 63.2161.
(b) For each CEMS, you must keep the records listed in paragraphs
(b)(1) through (9) of this section.
(1) Records described in Sec. 63.10(b)(2)(vi).
(2) All required measurements needed to demonstrate compliance with
a relevant standard (including, but not limited to, CEMS data, raw
performance testing measurements, and raw performance evaluation
measurements that support data that you are required to report).
(3) Records described in Sec. 63.10(b)(2)(viii) through (xi). The
CEMS system must allow the amount of excess zero (low-level) and high-
level calibration drift measured at the interval checks to be
quantified and recorded.
(4) All required CEMS measurements (including monitoring data
recorded during CEMS breakdowns and out-of-control periods).
(5) Identification of each time period during which the CEMS was
inoperative, except for zero (low-level) and high-level checks.
(6) Identification of each time period during which the CEMS was
out of control, as defined in Sec. 63.2163(k).
(7) Current version of the performance evaluation test plan, as
specified in Sec. 63.8(d)(2), including the program of corrective
action for a malfunctioning CEMS, and previous (i.e., superseded)
versions of the performance evaluation test plan for a period of 5
years after each revision to the plan. The program of corrective action
should be included in the plan required under Sec. 63.8(d)(2).
(8) Request for alternatives to relative accuracy test audits for
CEMS as required in Sec. 63.8(f)(6)(i).
(9) Records of each deviation from monitoring system requirements,
including a description and explanation of each deviation.
(c) You must keep the records required in Table 4 to this subpart
to show continuous compliance with each emission limitation that
applies to you.
(d) You must also keep the records listed in paragraphs (d)(1)
through (3) of this section for each batch in your affected source.
(1) Unique batch identification number.
(2) Fermentation stage for which you are using the fermenter.
(3) Unique CEMS equipment identification number.
Sec. 63.2183 In what form and how long must I keep my records?
(a) Your records must be in a form suitable and readily available
for expeditious review, according to Sec. 63.10(b)(1).
(b) As specified in Sec. 63.10(b)(1), you must keep each record
for 5 years following the date of each occurrence, measurement,
maintenance, corrective action, report, or record.
(c) You must keep each record on site for at least 2 years after
the date of each occurrence, measurement, maintenance, corrective
action, report, or record, according to Sec. 63.10(b)(1). You may keep
the records off site for the remaining 3 years.
(d) You must keep written procedures documenting the CEMS quality
control program on record for the life of the affected source or until
the affected source is no longer subject to the provisions of this
part, to be made available for inspection, upon request, by the
Administrator.
Other Requirements and Information
Sec. 63.2190 What parts of the General Provisions apply to me?
Table 6 to this subpart shows which parts of the General Provisions
in Sec. Sec. 63.1 through 63.13 apply to you.
Sec. 63.2191 Who implements and enforces this subpart?
(a) We, the U.S. EPA, or a delegated authority such as your state,
local, or tribal agency, can implement and enforce this subpart. If our
Administrator has delegated authority to your state, local, or tribal
agency, then that agency has the authority to implement and enforce
this subpart. You should contact the U.S. EPA Regional Office that
serves you to find out if this subpart is delegated to your state,
local, or tribal agency.
(b) In delegating implementation and enforcement authority of this
subpart to a state, local, or tribal agency under 40 CFR part 63,
subpart E, the authorities contained in paragraph (c) of this section
are retained by our Administrator and are not transferred to the state,
local, or tribal agency.
(c) The authorities that will not be delegated to state, local, or
tribal agencies are listed in paragraphs (c)(1) through (4) of this
section.
(1) Approval of alternatives to the non-opacity emission
limitations in Sec. 63.2140 under Sec. 63.6(g).
(2) Approval of major alternatives to test methods under Sec.
63.7(e)(2)(ii) and (f) and as defined in Sec. 63.90.
(3) Approval of major alternatives to monitoring under Sec.
63.8(f) and as defined in Sec. 63.90.
(4) Approval of major alternatives to recordkeeping and reporting
under Sec. 63.10(f) and as defined in Sec. 63.90.
Sec. 63.2192 What definitions apply to this subpart?
Terms used in this subpart are defined in the Clean Air Act, in 40
CFR 63.2, the General Provisions of this part, and in this section as
follows:
Batch means a single fermentation cycle in a single fermentation
vessel (fermenter).
Batch monitoring period means the period that begins at the later
of either the start of aeration or the addition of yeast to the
fermenter; the period ends at the earlier of either the end of aeration
or the point at which the yeast has begun being emptied from the
fermenter.
Brew means the mixture of yeast and additives in the fermenter.
Brew ethanol means the ethanol in fermenter liquid.
Brew ethanol monitor means the monitoring system that you use to
[[Page 95844]]
measure brew ethanol to demonstrate compliance with this subpart. The
monitoring system includes a resistance element used as an ethanol
sensor, with the measured resistance proportional to the concentration
of ethanol in the brew.
Brew-to-exhaust correlation means the correlation between the
concentration of ethanol in the brew and the concentration of VOC in
the fermenter exhaust. This correlation is specific to each fed-batch
fermentation stage and is established while manufacturing the product
that comprises the largest percentage (by mass) of average annual
production.
Emission limitation means any emission limit or operating limit.
Fed-batch means the yeast is fed carbohydrates and additives during
fermentation in the vessel.
Monitoring system malfunction means any sudden, infrequent, and not
reasonably preventable failure of the monitoring system to provide
valid data. Monitoring system failures that are caused in part by poor
maintenance or careless operation are not malfunctions. You are
required to complete monitoring system repairs in response to
monitoring system malfunctions and to return the monitoring system to
operation as expeditiously as practicable.
1-hour period means any 60-minute period commencing on the minute
at which the batch monitoring period begins.
Product means the yeast resulting from the final stage in a
production run. Products are distinguished by yeast species, strain,
and variety.
Responsible official means responsible official as defined in 40
CFR 70.2.
Set-batch means the yeast is fed carbohydrates and additives only
at the start of the batch.
Specialty yeast includes but is not limited to yeast produced for
use in wine, champagne, whiskey, and beer.
Within-concentration batch means a batch for which the average VOC
concentration is not higher than the maximum concentration that is
allowed as part of the applicable emission limitation.
Table 1 to Subpart CCCC of Part 63--Emission Limitations
----------------------------------------------------------------------------------------------------------------
Before [date of On and after [date of publication of the final
publication of the rule in the Federal Register], you must comply
final rule in the with either the Average Option or the Batch
For each fed-batch fermenter Federal Register] . . . Option . . .
producing yeast in the following --------------------------------------------------------------------------
fermentation stage . . . You must not exceed the Average Option: You Batch Option: You must
following VOC emission must not exceed the not exceed the
limitation \a\ . . . following VOC emission following VOC emission
limitation \a\ . . . limitation \a\ . . .
----------------------------------------------------------------------------------------------------------------
Last stage........................... 100 parts per million 95 ppmv (measured as 100 ppmv (measured as
by volume (ppmv) propane) for the propane) for the
(measured as propane) average VOC average VOC
in the fermenter concentration in the concentration in the
exhaust for at least fermenter exhaust from fermenter exhaust for
98 percent of all all batches \b\ in each batch.\b\
batches \b\ in each 12- this stage in each 12-
month calculation month calculation
period described in period \c\.
Sec. 63.2171(b).
Second-to-last stage................. 200 ppmv (measured as 190 ppmv (measured as 200 ppmv (measured as
propane) in the propane) for the propane) for the
fermenter exhaust for average VOC average VOC
at least 98 percent of concentration in the concentration in the
all batches \b\ in fermenter exhaust from fermenter exhaust for
each 12-month all batches\b\ in this each batch.\b\
calculation period stage in each 12-month
described in Sec. calculation period \c\.
63.2171(b).
Third-to-last stage.................. 300 ppmv (measured as 285 ppmv (measured as 300 ppmv (measured as
propane) in the propane) for the propane) for the
fermenter exhaust for average VOC average VOC
at least 98 percent of concentration in the concentration in the
all batches \b\ in fermenter exhaust from fermenter exhaust for
each 12-month all batches \b\ in each batch.\b\
calculation period this stage in each 12-
described in Sec. month calculation
63.2171(b). period \c\.
----------------------------------------------------------------------------------------------------------------
\a\ The emission limitation does not apply during the production of specialty yeast.
\b\ The average VOC concentration for each batch equals the average VOC concentration over the duration of a
batch.
\c\ Determined as the average of all batch-average VOC concentration data for this stage in each 12-month
calculation period as described in Sec. Sec. 63.2160(a) and 63.2171(c).
Table 2 to Subpart CCCC of Part 63--Requirements for Performance Tests
If You Monitor Brew Ethanol
------------------------------------------------------------------------
For each fed-batch fermenter for
which compliance is determined
by monitoring brew ethanol
concentration and calculating According to the
VOC concentration in the Using . . . following
fermenter exhaust according to requirements . . .
the procedures in Sec.
63.2161, you must . . .
------------------------------------------------------------------------
Measure VOC as propane.......... Method 25A \a\, or You must measure
an alternative the VOC
validated by EPA concentration in
Method 301 \b\ the fermenter
and approved by exhaust at any
the Administrator. point prior to
the dilution of
the exhaust
stream.
------------------------------------------------------------------------
\a\ EPA Test Method 25A is found in appendix A-7 of 40 CFR part 60.
\b\ EPA Test Method 301 is found in appendix A of 40 CFR part 63.
[[Page 95845]]
Table 3 to Subpart CCCC of Part 63--Initial Compliance With Emission Limitations
----------------------------------------------------------------------------------------------------------------
Before [date of On and after [date of publication of the final
publication of the rule in the Federal Register] . . .
final rule in the -------------------------------------------------
For . . . Federal Register], you Average Option: You
have demonstrated have demonstrated Batch Option: You have
initial compliance if . initial compliance if . demonstrated initial
. . . . compliance if . . .
----------------------------------------------------------------------------------------------------------------
Each fed-batch fermenter producing The average VOC The average VOC The average VOC
yeast in a fermentation stage (last concentration in the concentration in the concentration in the
(Trade), second-to-last (First fermenter exhaust for fermenter exhaust from fermenter exhaust for
Generation), or third-to-last at least 98 percent of all batches in each each batch of each
(Stock)) for which compliance is the batches (sum of fermentation stage fermentation stage
determined by monitoring VOC batches from last, during the initial during the initial
concentration in the fermenter second-to-last, and compliance period compliance period
exhaust. third-to-last stages) described in Sec. described in Sec.
during the initial 63.2160(a) does not 63.2160(b) does not
compliance period does exceed the applicable exceed the applicable
not exceed the concentration in Table concentration in Table
applicable maximum 1 to this subpart. 1 to this subpart.
concentration in Table
1 to this subpart.
----------------------------------------------------------------------------------------------------------------
Table 4 to Subpart CCCC of Part 63--Continuous Compliance With Emission Limitations
----------------------------------------------------------------------------------------------------------------
Before [date of On and after [date of publication of the final
publication of the rule in the Federal Register] . . .
final rule in the -------------------------------------------------
For . . . Federal Register], you Average Option: You
must demonstrate must demonstrate Batch Option: You must
continuous compliance continuous compliance demonstrate continuous
by . . . by . . . compliance by . . .
----------------------------------------------------------------------------------------------------------------
1. Each fed-batch fermenter producing Showing that for at Showing that the Showing that the
yeast in a fermentation stage (last least 98 percent of average VOC average VOC
(Trade), second-to-last (First the batches (sum of concentration in the concentration in the
Generation), or third-to-last batches from last, fermenter exhaust from fermenter exhaust for
(Stock)) for which compliance is second-to-last, and all batches in each each batch within a
determined by monitoring VOC third-to-last stages) fermentation stage semiannual reporting
concentration in the fermenter for each 12-month during each 12-month period described in
exhaust. period ending within a calculation period Sec. 63.2181(b)(3)
semiannual reporting ending within a does not exceed the
period described in semiannual reporting applicable
Sec. 63.2181(b)(3), period described in concentration in Table
the batch-average VOC Sec. 63.2181(b)(3) 1 to this subpart.
concentration in the does not exceed the
fermenter exhaust does applicable
not exceed the concentration in Table
applicable maximum 1 to this subpart.
concentration in Table
1 to this subpart.
2. Each fed-batch fermenter producing Showing that for at Showing that the Showing that the
yeast in a fermentation stage (last least 98 percent of average VOC average VOC
(Trade), second-to-last (First the batches (sum of concentration in the concentration in the
Generation), or third-to-last batches from last, fermenter exhaust from fermenter exhaust for
(Stock)) for which compliance is second-to-last, and all batches in each each batch within a
determined by monitoring brew third-to-last stages) fermentation stage semiannual reporting
ethanol concentration and for each 12-month during each 12-month period described in
calculating VOC concentration in the period ending within a calculation period Sec. 63.2181(b)(3)
fermenter exhaust according to the semiannual reporting ending within a does not exceed the
procedures in Sec. 63.2161. period described in semiannual reporting applicable
Sec. 63.2181(b)(3), period described in concentration in Table
the batch-average VOC Sec. 63.2181(b)(3) 1 to this subpart.\a\
concentration in the does not exceed the
fermenter exhaust does applicable
not exceed the concentration in Table
applicable maximum 1 to this subpart \a\.
concentration in Table
1 to this subpart.
----------------------------------------------------------------------------------------------------------------
\a\ Monitoring brew ethanol to demonstrate compliance is not allowed on and after [date one year after the date
of publication of the final rule in the Federal Register], as specified in Sec. 63.2171(a)(2).
Table 5 to Subpart CCCC of Part 63--Requirements for Reports
------------------------------------------------------------------------
The report must You must submit
You must submit a . . . contain . . . the report . . .
------------------------------------------------------------------------
1. Compliance report............ a. The information Semiannually
described in Sec. according to the
63.2181(c), for requirements in
12-month Sec.
calculation 63.2181(b).
periods ending on
each calendar
month that falls
within the
reporting period.
b. If you had a Semiannually
malfunction according to the
during the requirements in
reporting period, Sec.
then the 63.2181(b).
compliance report
must include the
information in
Sec.
63.2181(c)(5) and
(7).
2. Performance Evaluation Report The results of the At least annually
performance and according to
evaluation, the requirements
including in Sec. Sec.
information from 63.2163(f) and
the performance 63.2181(a)(1)(ii)
evaluation plan .
at 63.8(e)(3).
------------------------------------------------------------------------
[[Page 95846]]
Table 6 to Subpart CCCC of Part 63--Applicability of General Provisions
to Subpart CCCC
------------------------------------------------------------------------
Applicable to subpart
Citation Subject CCCC?
------------------------------------------------------------------------
Sec. 63.1................... Applicability.... Yes.
Sec. 63.2................... Definitions...... Yes.
Sec. 63.3................... Units and Yes.
Abbreviations.
Sec. 63.4................... Prohibited Yes.
Activities and
Circumvention.
Sec. 63.5................... Construction and Yes.
Reconstruction.
Sec. 63.6................... Compliance With 1. Sec.
Standards and 63.6(e)(1)(i) does
Maintenance not apply, instead
Requirements. specified in Sec.
63.2150(c).
2. Sec.
63.6(e)(1)(ii),
(e)(3), (f)(1), and
(h) do not apply.
3. Otherwise, all
apply.
Sec. 63.7................... Performance 1. Sec. 63.7(a)(1)-
Testing (2) do not apply,
Requirements. instead specified in
Sec. 63.2162.
2. Sec. 63.7(e)(1)
and (e)(3) do not
apply, instead
specified in Sec.
63.2161(b).
3. Otherwise, all
apply.
Sec. 63.8................... Monitoring 1. Sec. 63.8(a)(2)
Requirements. is modified by Sec.
63.2163.
2. Sec. 63.8(d)(3)
does not apply,
instead specified in
Sec. 63.2182(b)(7)
and Sec.
63.2183(d).
3. Sec. 63.8(a)(4),
(c)(1)(i),
(c)(1)(iii),
(c)(4)(i), (c)(5),
(e)(5)(ii), and
(g)(5) do not apply.
4. Sec.
63.8(c)(4)(ii),
(c)(6)-(8), (e)(4),
and (g)(1)-(4) do
not apply, instead
specified in Sec.
63.2163, Sec.
63.2170(b), and Sec.
63.2182(b)(6).
5. Otherwise, all
apply.
Sec. 63.9................... Notification 1. Sec. 63.9(b)(2)
Requirements. does not apply
because rule omits
requirements for
initial notification
for affected sources
that start up prior
to May 21, 2001.
2. Sec. 63.9(f)
does not apply.
3. Otherwise, all
apply.
Sec. 63.10.................. Recordkeeping and 1. Sec.
Reporting 63.10(b)(2)(ii) does
Requirements. not apply, instead
specified in Sec.
63.2182(a)(2).
2. Sec. 63.10(c)(1)-
(6) do not apply,
instead specified in
Sec. 63.2182(b)(4)-
(6).
3. Sec. 63.10
(b)(2)(i),
(b)(2)(iv),
(b)(2)(v), (c)(15),
(d)(3), (e)(2)(ii),
and (e)(3)-(4) do
not apply.
4. Sec. 63.10(d)(5)
does not apply,
instead specified in
Sec. 63.2181(c)(5)
and (7).
5. Otherwise, all
apply.
Sec. 63.11.................. Flares........... No.
Sec. 63.12.................. Delegation....... Yes.
Sec. 63.13.................. Addresses........ Yes.
Sec. 63.14.................. Incorporation by Yes.
Reference.
Sec. 63.15.................. Availability of Yes.
Information.
------------------------------------------------------------------------
[FR Doc. 2016-30645 Filed 12-27-16; 8:45 am]
BILLING CODE 6560-50-P